Detecting improper energy transmission configuration in medical device system

ABSTRACT

A medical device system may be configured to detect an improper energy transmission configuration therein. The condition may be detected by way of a detection of a condition where an energy-transmitting electrode of the medical device system becomes too close to or becomes in contact with an object resulting in an inability of the electrode to properly transmit energy. For example, if the energy-transmitting electrode is a first electrode configured in its operational state to transmit energy to bodily tissue adjacent the first electrode, but the first electrode is inadvertently contacting a second electrode, such contact may cause at least some energy transmitted by the first electrode to follow an unintended path away from its intended path to the adjacent tissue. Such a condition may be detected based at least upon an analysis of information acquired from a sensing device system.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.61/780,824, filed Mar. 13, 2013, the entire disclosure of which ishereby incorporated herein by reference.

TECHNICAL FIELD

Aspects of this disclosure generally are related to detecting one ormore improper energy transmission configurations in systems in whichsuccessful energy transmission is a priority, such as, but not limitedto, medical device systems where energy transmission may need to beproperly controlled to successfully treat a patient or at least avoidunintended consequences.

BACKGROUND

Cardiac surgery was initially undertaken using highly invasive openprocedures. A sternotomy, which is a type of incision in the center ofthe chest that separates the sternum was typically employed to allowaccess to the heart. In the past several decades, more and more cardiacoperations are performed using intravascular or percutaneous techniques,where access to inner organs or other tissue is gained via a catheter.

Intravascular or percutaneous surgeries benefit patients by reducingsurgery risk, complications and recovery time. However, the use ofintravascular or percutaneous technologies also raises some particularchallenges. Medical devices used in intravascular or percutaneoussurgery need to be deployed via catheter systems which significantlyincrease the complexity of the device structure. As well, doctors do nothave direct visual contact with the medical devices once the devices arepositioned within the body.

One example of where intravascular or percutaneous medical techniqueshave been employed is in the treatment of a heart disorder called atrialfibrillation. Atrial fibrillation is a disorder in which spuriouselectrical signals cause an irregular heartbeat. Atrial fibrillation hasbeen treated with open heart methods using a technique known as the“Cox-Maze procedure”. During this procedure, physicians create specificpatterns of lesions in the left and right atria to block various pathstaken by the spurious electrical signals. Such lesions were originallycreated using incisions, but are now typically created by ablating thetissue with various techniques including radio-frequency (RF) energy,microwave energy, laser energy and cryogenic techniques. The procedureis performed with a high success rate under the direct vision that isprovided in open procedures, but is relatively complex to performintravascularly or percutaneously because of the difficulty in creatingthe lesions in the correct locations. Various problems, potentiallyleading to severe adverse results, may occur if the lesions are placedincorrectly. It is particularly important to know the position of thevarious transducers that may include electrodes operable for creatingthe lesions relative to cardiac features such as the pulmonary veins andmitral valve. The continuity, transmurality and placement of the lesionpatterns that are formed can impact the ability to block paths takenwithin the heart by spurious electrical signals. Accordingly, it can becritically important to ensure that the lesion patterns are properlyformed and placed.

In this regard, there is a need for techniques that ensure that lesionsare properly formed and placed or ensure that improperly formed orplaced lesions are prevented.

SUMMARY

At least the above-discussed need is addressed and technical solutionsare achieved by various embodiments of the present invention. In someembodiments, device systems and methods executed by such systems exhibitenhanced capabilities for the detection of one or more improper energytransmission configurations in systems in which energy transmission is apriority, such as, but not limited to, medical device systems whereenergy transmission may need to be properly controlled to successfullytreat a patient or at least avoid unintended consequences. In someembodiments, one or more positional deviations associated with one ormore electrodes are detected, the one or more electrodes may be locatedwithin a bodily cavity such as an intra-cardiac cavity. In someembodiments, the suitability of one or more electrodes for tissueablation, such as cardiac tissue ablation, is detected. In someembodiments, the system or systems, or a portion thereof, may bepercutaneously or intravascularly delivered to position variouselectrodes within the bodily cavity. Various ones of the electrodes maybe used to treat tissue within a bodily cavity. Treatment may includetissue ablation by way of non-limiting example. Various ones of theelectrodes may be used to map tissue within the bodily cavity. Mappingcan include mapping electrophysiological activity by way of non-limitingexample. Mapping may be employed in a diagnosis of various conditions.Various ones of the electrodes may be used to stimulate tissue withinthe bodily cavity. Stimulation can include pacing by way of non-limitingexample. Other characteristics and advantages will become apparent fromthe teaching herein to those of skill in the art. In some embodiments, amedical device system medical system may be summarized as including adata processing device system and a memory device system communicativelyconnected to the data processing device system and storing a programexecutable by the data processing device system. The program includesacquisition instructions configured to cause an acquisition ofinformation stored in the memory device system. The program includesdetection instructions configured to cause a detection of a shuntcondition created in an electric circuit based at least upon an analysisof the information acquired according to the acquisition instructions.The electric circuit includes at least a first electrode of one or moreelectrodes of an electrode-based device system that includes a structureand the one or more electrodes which are located on the structure. Theone or more electrodes are positionable in a bodily cavity defined atleast in part by a tissue wall. The shunt condition is associated with adiversion of a portion, but not all, of energy transmittable by thefirst electrode of the one or more electrodes away from adjacent tissueof the tissue wall, the adjacent tissue adjacent the first electrode ofthe one or more electrodes. The energy transmittable by the firstelectrode of the one or more electrodes is sufficient for tissueablation. The program further includes storage instructions configuredto cause a storage in the memory device system of detection informationindicating the detection of the shunt condition according to thedetection instructions.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including the electrode-based devicesystem. The program may further include reception instructionsconfigured to cause (a) a reception of first information from theelectrode-based device system, and (b) a storage of the firstinformation or a derivative thereof in the memory device system. Theinformation acquired according to the acquisition instructions may bethe first information or the derivative of the first information storedin the memory device system according to the reception instructions. Theelectrode-based device system may include one or more transducers, theone or more transducers configured to, while positioned in the bodilycavity, provide one or more electrical signals to the tissue wall. Thefirst information or the derivative thereof may indicate a result of aninteraction between the one or more electrical signals and the tissuewall, and the one or more electrical signals may include one or moreenergy levels insufficient for tissue ablation.

The medical device system may further include the electrode-based devicesystem, which is communicatively connected to the data processing devicesystem. The program may further include restriction instructionsconfigured to cause a restriction of the energy transmittable by thefirst electrode of the one or more electrodes in response to thedetected shunt condition. The shunt condition may be associated with adiversion of the portion of energy transmittable by the first electrodeof the one or more electrodes from traveling along (a) a firstelectrical path extending from the first electrode of the one or moreelectrodes to the adjacent tissue of the tissue wall, to (b) a secondelectrical path extending from the first electrode of the one or moreelectrodes away from the adjacent tissue of the tissue wall. The shuntcondition may be associated with a diversion of the portion of energytransmittable by the first electrode of the one or more electrodes to anelectrically conductive portion of the structure. The shunt conditionmay be associated with a diversion of the portion of energytransmittable by the first electrode of the one or more electrodes to ametallic portion of the structure. The shunt condition may be associatedwith a diversion of the portion of energy transmittable by the firstelectrode of the one or more electrodes to a second electrodepositionable in the bodily cavity. The one or more electrodes mayinclude a second electrode, and the shunt condition may be associatedwith a diversion of the portion of energy transmittable by the firstelectrode of the one or more electrodes to the second electrode of theone or more electrodes. The shunt condition may be configured to occurat least due to contact between the first electrode of the one or moreelectrodes and a non-tissue based electrically conductive surfacepositionable in the bodily cavity. The non-tissue based electricallyconductive surface may not form part of any electrode. The shuntcondition may be configured to occur at least due to contact between thefirst electrode of the one or more electrodes and a metallic surfacepositionable in the bodily cavity. The shunt condition may be configuredto occur at least due to contact between the first electrode of the oneor more electrodes and an electrically conductive portion of thestructure. The shunt condition may be configured to occur at least dueto contact between the first electrode of the one or more electrodes anda second electrode positionable in the bodily cavity. The one or moreelectrodes may include a second electrode, and the shunt condition maybe configured to occur at least due to contact between the firstelectrode of the one or more electrodes and the second electrode of theone or more electrodes.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,and the program may further include failure state instructionsconfigured to cause the input-output device system to present an errornotification to a user in response to the detection of the shuntcondition according to the detection instructions.

The information acquired according to the acquisition instructions mayinclude impedance information associated with at least the firstelectrode of the one or more electrodes. The information acquiredaccording to the acquisition instructions may include positionalinformation indicative of a deviation in an expected positioning betweenthe first electrode of the one or more electrodes and a physical portionof the electrode-based device system. The information acquired accordingto the acquisition instructions may include positional informationindicative of a deviation in an expected positioning between a portionof the structure and the adjacent tissue of the tissue wall.

The medical device system may further include the electrode-based devicesystem, which is communicatively connected to the data processing devicesystem. The structure of the electrode-based device system may include aplurality of elongate members. The one or more electrodes may include aplurality of the electrodes, at least some of the plurality of theelectrodes located on each of the plurality of elongate members. Thefirst electrode of the one or more electrodes may be located on a firstelongate member of the plurality of elongate members. The informationacquired according to the acquisition instructions may includepositional information indicative of a deviation in an expectedpositioning between the first electrode of the one or more electrodesand at least a second elongate member of the plurality of elongatemembers, the first elongate member being other than the second elongatemember. The structure may be selectively moveable between a deliveryconfiguration in which the structure is sized for percutaneous deliveryto the bodily cavity and a deployed configuration in which the structureis sized too large for percutaneous delivery to the bodily cavity.

The medical device system may further include the electrode-based devicesystem, which is communicatively connected to the data processing devicesystem. The electric circuit may include a first electrical pathextending at least from the first electrode of the one or moreelectrodes to a second electrode. The first electrical path may extendat least from the first electrode of the one or more electrodes to thesecond electrode via the adjacent tissue. The shunt condition may beassociated with a diversion of the portion of energy transmittable bythe first electrode from the first electrical path to a secondelectrical path other than the first electrical path, the secondelectrical path extending from the first electrode of the one or moreelectrodes to the second electrode. The second electrical path mayextend from the first electrode of the one or more electrodes to thesecond electrode via tissue other than the adjacent tissue. The secondelectrode may be an indifferent electrode positioned outside of thebodily cavity. The second electrode may be positionable in the bodilycavity. The one or more electrodes may include the second electrode.

The shunt condition may be associated with a smaller portion of theenergy transmittable by the first electrode of the one or moreelectrodes being receivable by the adjacent tissue as compared to anunshunted condition. The shunt condition may be associated with anincrease in the diversion of the portion of the energy transmittable bythe first electrode of the one or more electrodes.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including a sensing device system. Theprogram may further include reception instructions configured to cause(a) a reception of first information from the sensing device system, and(b) a storage of the first information or a derivative thereof in thememory device system, and the information acquired according to theacquisition instructions may be the first information or the derivativeof the first information stored in the memory device system according tothe reception instructions.

In some embodiments, various systems may include combinations andsubsets of the systems summarized above.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and a memory device systemcommunicatively connected to the data processing device system andstoring a program executable by the data processing device system. Thedata processing device system is configured by the program at least toacquire information stored in the memory device system and detect ashunt condition created in an electric circuit based at least upon ananalysis of the acquired information. The electric circuit includes atleast a first electrode of one or more electrodes of an electrode-baseddevice system that includes a structure and the one or more electrodeslocated on the structure, the one or more electrodes positionable in abodily cavity defined at least in part by a tissue wall. The shuntcondition is associated with a diversion of a portion, but not all, ofenergy transmittable by the first electrode of the one or moreelectrodes away from adjacent tissue of the tissue wall, the adjacenttissue adjacent the first electrode of the one or more electrodes, andthe energy transmittable by the first electrode of the one or moreelectrodes sufficient for tissue ablation. The data processing devicesystem is configured by the program to store, in the memory devicesystem, detection information indicating the detection of the shuntcondition.

In some embodiments, a method is executed by a data processing devicesystem according to a program stored by a memory device systemcommunicatively connected to the data processing device system. Themethod may be summarized as including acquiring information stored inthe memory device system and detecting a shunt condition created in anelectric circuit based at least upon an analysis of the acquiredinformation. The electric circuit includes at least a first electrode ofone or more electrodes of an electrode-based device system that includesa structure and the one or more electrodes located on the structure, theone or more electrodes positionable in a bodily cavity defined at leastin part by a tissue wall. The shunt condition is associated with adiversion of a portion, but not all, of energy transmittable by thefirst electrode of the one or more electrodes away from adjacent tissueof the tissue wall, the adjacent tissue adjacent the first electrode ofthe one or more electrodes. The energy transmittable by the firstelectrode of the one or more electrodes is sufficient for tissueablation. The method further includes storing, in the memory devicesystem, detection information indicating the detection of the shuntcondition.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system. The program includes an acquisitionmodule configured to cause an acquisition of information stored in amemory device system and a detection module configured to cause adetection of a shunt condition created in an electric circuit based atleast upon an analysis of the information acquired according to theacquisition instructions. The electric circuit includes at least a firstelectrode of one or more electrodes of an electrode-based device systemthat includes a structure and the one or more electrodes located on thestructure, the one or more electrodes positionable in a bodily cavitydefined at least in part by a tissue wall. The shunt condition isassociated with a diversion of a portion, but not all, of energytransmittable by the first electrode of the one or more electrodes awayfrom adjacent tissue of the tissue wall, the adjacent tissue adjacentthe first electrode of the one or more electrodes. The energytransmittable by the first electrode of the one or more electrodes issufficient for tissue ablation. The program further includes a storagemodule configured to cause a storage in the memory device system ofdetection information indicating the detection of the shunt conditionaccording to the detection module. In some embodiments, thecomputer-readable storage medium system is a non-transitorycomputer-readable storage medium system that includes one or morenon-transitory computer-readable storage mediums.

In some embodiments, a medical device may be summarized as including adata processing device system and a memory device system communicativelyconnected to the data processing device system and storing a programexecutable by the data processing device system. The program includesacquisition instructions configured to cause an acquisition ofinformation stored in the memory device system. The program includesdetection instructions configured to cause a detection of a shuntcondition based at least upon an analysis of the information acquiredaccording to the acquisition instructions. The shunt condition isassociated with a diversion of a portion of energy transmittable by atleast a first electrode of a plurality of electrodes of anelectrode-based device system that includes a structure on which each ofthe plurality of electrodes is located. The plurality of electrodes arepositionable in a bodily cavity. The structure is selectively movablebetween a delivery configuration in which the structure is sized forpercutaneous delivery to the bodily cavity and a deployed configurationin which the structure is sized too large for percutaneous delivery tothe bodily cavity. The program further includes determinationinstructions configured to cause a determination of, at least inresponse to the detected shunt condition, a deviation in an expectedpositioning between the first electrode of the plurality of electrodesand a physical portion of the electrode-based device system at leastwhen the structure is in the deployed configuration, and storageinstructions configured to cause a storage in the memory device systemof determination information indicating a result of the determination ofthe deviation according to the determination instructions.

The medical device system may further include the electrode-based devicesystem, which is communicatively connected to the data processing devicesystem.

The program may further include restriction instructions configured tocause a restriction of the energy transmittable by at least the firstelectrode of the plurality of electrodes in response to the detectedshunt condition.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including the electrode-based devicesystem. The program may further include reception instructionsconfigured to cause (a) a reception of first information from theelectrode-based device system, and (b) a storage of the firstinformation or a derivative thereof in the memory device system, and theinformation acquired according to the acquisition instructions may bethe first information or the derivative of the first information storedin the memory device system according to the reception instructions.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including a sensing device system. Theprogram may further include reception instructions configured to cause(a) a reception of first information from the sensing device system, and(b) a storage of the first information or a derivative thereof in thememory device system, and the information acquired according to theacquisition instructions may be the first information or the derivativeof the first information stored in the memory device system according tothe reception instructions.

The bodily cavity is defined at least in part by a tissue wall, and theshunt condition may be associated with a diversion of the portion oftransmittable energy from traveling (a) along a first electrical pathextending from the first electrode of the plurality of electrodes toadjacent tissue of the tissue wall to (b) a second electrical pathextending from the first electrode of the plurality of electrodes awayfrom the adjacent tissue of the tissue wall, the adjacent tissueadjacent the first electrode of the plurality of electrodes.

The medical device system may further include the electrode-based devicesystem, which is communicatively connected to the data processing devicesystem. The shunt condition may be associated with a diversion of theportion of energy transmittable by the first electrode of the pluralityof electrodes to an electrically conductive portion of the structure.The shunt condition may be associated with a diversion of the portion ofenergy transmittable by the first electrode of the plurality ofelectrodes to a metallic portion of the structure. The shunt conditionmay be associated with a diversion of the portion of energytransmittable by the first electrode of the plurality of electrodes to asecond electrode positionable in the bodily cavity. The plurality ofelectrodes may include a second electrode, and the shunt condition maybe associated with a diversion of the portion of energy transmittable bythe first electrode of the plurality of electrodes to the secondelectrode of the plurality of electrodes. The shunt condition may beassociated with contact between the first electrode of the plurality ofelectrodes and a non-tissue based electrically conductive surfacepositionable in the bodily cavity. The non-tissue based electricallyconductive surface may not form part of any electrode.

The information acquired according to the acquisition instructions mayinclude impedance information associated with at least the firstelectrode of the plurality of electrodes.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including the electrode-based devicesystem. The program may further include reception instructionsconfigured to cause (a) a reception of first information from theelectrode-based device system, and (b) a storage of the firstinformation or a derivative thereof in the memory device system, and theinformation acquired according to the acquisition instructions may bethe first information or the derivative of the first information storedin the memory device system according to the reception instructions. Thebodily cavity is defined at least part by a tissue wall, and theelectrode-based device system may include one or more transducers, theone or more transducers configured to, while positioned in the bodilycavity, provide one or more electrical signals to the tissue wall. Thefirst information or the derivative thereof may indicate a result of aninteraction between the one or more electrical signals and the tissuewall. The one or more electrical signals may include one or more energylevels insufficient for tissue ablation.

The medical device system may further include the electrode-based devicesystem, which is communicatively connected to the data processing devicesystem. The shunt condition may be associated with at least a portion ofthe first electrode being overlapped by a structural member of thestructure at least when the structure is in the deployed configuration.The structure may include one or more elongate members, at least some ofthe plurality of the electrodes located on each of the one or moreelongate members. The shunt condition may be associated with at least aportion of the first electrode being overlapped by an elongate member ofthe one or more elongate members at least when the structure is in thedeployed configuration. The structure may include a plurality ofelongate members, the first electrode located on a first elongate memberof the plurality of elongate members. The shunt condition may beassociated with at least a portion of the first electrode beingoverlapped by an elongate member of the plurality of elongate membersother than the first elongate member at least when the structure is inthe deployed configuration. In some embodiments, the physical portion ofthe electrode-based device system is a portion of the structure. In someembodiments, the physical portion of the electrode-based device systemis a second electrode. The plurality of electrodes may include thesecond electrode. The physical portion of the electrode-based devicesystem is positionable in the bodily cavity in some embodiments.

In some embodiments, various systems may include combinations andsubsets of the systems summarized above.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and a memory device systemcommunicatively connected to the data processing device system andstoring a program executable by the data processing device system. Thedata processing device system is configured by the program at least toacquire information stored in the memory device system and detect ashunt condition based at least upon an analysis of the acquiredinformation. The shunt condition is associated with a diversion of aportion of energy transmittable by at least a first electrode of aplurality of electrodes of an electrode-based device system thatincludes a structure on which each of the plurality of electrodes islocated, the plurality of electrodes positionable in a bodily cavity.The structure is selectively movable between a delivery configuration inwhich the structure is sized for percutaneous delivery to the bodilycavity and a deployed configuration in which the structure is sized toolarge for percutaneous delivery to the bodily cavity. The dataprocessing device system is further configured by the program todetermine, at least in response to the detected shunt condition, adeviation in an expected positioning between the first electrode of theplurality of electrodes and a physical portion of the electrode-baseddevice at least when the structure is in the deployed configuration; andstore, in the memory device system, determination information indicatinga result of the determination of the deviation.

In some embodiments, a method is executed by a data processing devicesystem according to a program stored by a memory device systemcommunicatively connected to the data processing device system. Themethod may be summarized as including acquiring information stored inthe memory device system and detecting a shunt condition based at leastupon an analysis of the acquired information. The shunt condition isassociated with a diversion of a portion of energy transmittable by atleast a first electrode of a plurality of electrodes of anelectrode-based device system that includes a structure on which each ofthe plurality of electrodes is located, the plurality of electrodespositionable in a bodily cavity. The structure is selectively movablebetween a delivery configuration in which the structure is sized forpercutaneous delivery to the bodily cavity and a deployed configurationin which the structure is sized too large for percutaneous delivery tothe bodily cavity. The method further includes determining, at least inresponse to the detected shunt condition, a deviation in an expectedpositioning between the first electrode of the plurality of electrodesand a physical portion of the electrode-based device at least when thestructure is in the deployed configuration, and storing, in the memorydevice system, determination information indicating a result of thedetermination of the deviation.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system. The program includes an acquisitionmodule configured to cause an acquisition of information stored in amemory device system and a detection module configured to cause adetection of a shunt condition based at least upon an analysis of theinformation acquired according to the acquisition module. The shuntcondition is associated with a diversion of a portion of energytransmittable by at least a first electrode of a plurality of electrodesof an electrode-based device system that includes a structure on whicheach of the plurality of electrodes is located, the plurality ofelectrodes positionable in a bodily cavity. The structure is selectivelymovable between a delivery configuration in which the structure is sizedfor percutaneous delivery to the bodily cavity and a deployedconfiguration in which the structure is sized too large for percutaneousdelivery to the bodily cavity. The program further includes adetermination module configured to cause a determination of, at least inresponse to the detected shunt condition, a deviation in an expectedpositioning between the first electrode of the plurality of electrodesand a physical portion of the electrode-based device at least when thestructure is in the deployed configuration, and a storage moduleconfigured to cause a storage in the memory device system ofdetermination information indicating a result of the determination ofthe deviation according to the determination module. In someembodiments, the computer-readable storage medium system is anon-transitory computer-readable storage medium system that includes oneor more non-transitory computer-readable storage mediums.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and a memory device systemcommunicatively connected to the data processing device system andstoring a program executable by the data processing device system. Theprogram includes acquisition instructions configured to cause anacquisition of information stored in the memory device system. Theprogram includes detection instructions configured to cause a detectionof a condition, based at least upon an analysis of the informationacquired according to the acquisition instructions. The conditionindicates that some, but not all, of a respective electricallyconductive surface portion of each of at least a first electrode of oneor more electrodes is available for contact with tissue of a tissue wallof a bodily cavity when a structure, on which each of the one or moreelectrodes is located, is positioned in the bodily cavity in a deployedconfiguration, the deployed configuration being different than adelivery configuration in which the structure is sized for percutaneousdelivery to the bodily cavity. The entirety of the respectiveelectrically conductive surface portion of each of at least the firstelectrode of the one or more electrodes is configured, in absence of thecondition, for contact with a contiguous surface portion of the tissuewall when the structure is positioned in the bodily cavity in thedeployed configuration. For each respective electrically conductivesurface portion, energy is transmittable between the respectiveelectrically conductive surface portion and the tissue wall, the energysufficient for tissue ablation. The program further includes storageinstructions configured to cause a storage in the memory device systemof detection information indicating the detection of the conditionaccording to the detection instructions.

The medical device system may further include an electrode-based devicesystem communicatively connected to the data processing device system,the electrode-based device system including the structure and the one ormore electrodes located on the structure, the structure selectivelymovable between the delivery configuration and the deployedconfiguration.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including the electrode-based devicesystem. The program may further include reception instructionsconfigured to cause (a) a reception of first information from theelectrode-based device system, and (b) a storage of the firstinformation or a derivative thereof in the memory device system, and theinformation acquired according to the acquisition instructions may bethe first information or the derivative of the first information storedin the memory device system according to the reception instructions.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including a sensing device system. Theprogram may further include reception instructions configured to cause(a) a reception of first information from the sensing device system, and(b) a storage of the first information or a derivative thereof in thememory device system, and the information acquired according to theacquisition instructions may be the first information or the derivativeof the first information stored in the memory device system according tothe reception instructions.

The may further include restriction instructions configured to cause arestriction of the energy transmittable by at least the first electrodeof the one or more electrodes in response to the detected condition. Themedical device system may further include an input-output device systemcommunicatively connected to the data processing device system and theprogram may further include failure state instructions configured tocause the input-output device system to present an error notification toa user in response to the detection of the condition according to thedetection instructions.

The medical device system may further include an electrode-based devicesystem communicatively connected to the data processing device system,the electrode-based device system including the structure and the one ormore electrodes located on the structure, the structure selectivelymovable between the delivery configuration and the deployedconfiguration. The condition may be associated with contact between anon-tissue based surface positioned in the bodily cavity and theelectrically conductive surface portion of the first electrode of theone or more electrodes when the structure is positioned in the bodilycavity in the deployed configuration. In some embodiments, thenon-tissue based surface does not form part of any electrode. Thecondition may be associated with contact between the electricallyconductive surface portion of the first electrode of the one or moreelectrodes and a portion of the structure when the structure ispositioned in the bodily cavity in the deployed configuration. Thecondition may be associated with contact between a second electrodepositioned in the bodily cavity and the electrically conductive surfaceportion of the first electrode of the one or more electrodes when thestructure is positioned in the bodily cavity in the deployedconfiguration. The one or more electrodes may include a secondelectrode, and the condition may be associated with contact between theelectrically conductive surface portion of the first electrode of theone or more electrodes and the second electrode of the one or moreelectrodes when the structure is positioned in the bodily cavity in thedeployed configuration. At least part of the electrically conductivesurface portion of the first electrode of the one or more electrodes maybe positioned to face towards a surface portion of the tissue wall whenthe structure is positioned in the bodily cavity in the deployedconfiguration, and the condition may be associated with a positioning ofa physical portion of the electrode-based device system between theelectrically conductive surface portion of the first electrode of theone or more electrodes and the surface portion of the tissue wall whenthe structure is positioned in the bodily cavity in the deployedconfiguration. At least part of the electrically conductive surfaceportion of the first electrode of the one or more electrodes may bepositioned to face towards a surface portion of the tissue wall when thestructure is positioned in the bodily cavity in the deployedconfiguration, and the condition may be associated with a positioning ofa portion of the structure between the electrically conductive surfaceportion of the first electrode of the one or more electrodes and thesurface portion of the tissue wall when the structure is positioned inthe bodily cavity in the deployed configuration.

The information acquired according to the acquisition instructions mayinclude impedance information associated with at least the firstelectrode of the one or more electrodes.

The medical device system may further include an electrode-based devicesystem communicatively connected to the data processing device system,the electrode-based device system including the structure and the one ormore electrodes located on the structure, the structure selectivelymovable between the delivery configuration and the deployedconfiguration. The information acquired according to the acquisitioninstructions may include positional information indicative of adeviation in an expected positioning between the first electrode of theone or more electrodes and a physical portion of the electrode-baseddevice system when the structure is positioned in the bodily cavity inthe deployed configuration. The electrode-based device system mayinclude one or more transducers, the one or more transducers configuredto, while positioned in the bodily cavity, provide one or moreelectrical signals to the tissue wall, and the first information or thederivative thereof may indicate a result of an interaction between theone or more electrical signals and the tissue wall. The one or moreelectrical signals may include one or more energy levels insufficientfor tissue ablation. The structure may include one or more elongatemembers and the one or more electrodes may include a plurality of theelectrodes, at least some of the plurality of the electrodes located oneach of the one or more elongate members. The first electrode of the oneor more electrodes may be located on a first elongate member of the oneor more elongate members, and the information acquired according to theacquisition instructions may include positional information indicativeof a deviation in an expected positioning between the first electrode ofthe one or more electrodes and an elongate member of the one or moreelongate members when the structure is positioned in the bodily cavityin the deployed configuration. The structure may include a plurality ofelongate members, and the one or more electrodes may include a pluralityof the electrodes, at least some of the plurality of the electrodeslocated on each of the plurality of elongate members. The firstelectrode of the one or more electrodes may be located on a firstelongate member of the plurality of elongate members, and theinformation acquired according to the acquisition instructions mayinclude positional information indicative of a deviation in an expectedpositioning between the first electrode of the one or more electrodesand at least a second elongate member of the plurality of elongatemembers when the structure is positioned in the bodily cavity in thedeployed configuration, the first elongate member being other than thesecond elongate member. The structure may include a plurality ofelongate members, each of the elongate members including a proximal end,a distal end, an intermediate portion positioned between the proximalend and the distal end, and a thickness, each intermediate portionincluding a front surface and a back surface opposite across thethickness of the elongate member from the front surface. The one or moreelectrodes may include a plurality of the electrodes, at least some ofthe plurality of the electrodes located on each of the respective frontsurfaces of the plurality of elongate members. The first electrode ofthe one or more electrodes may be located on the respective frontsurface of a first elongate member of the plurality of elongate members,and the information acquired according to the acquisition instructionsmay include positional information indicative of positioning where atleast part of the electrically conductive surface portion of the firstelectrode of the one or more electrodes faces the respective backsurface of a second elongate member of the plurality of elongate memberswhen the structure is positioned in the bodily cavity in the deployedconfiguration, the first elongate member being other than the secondelongate member.

In some embodiments, the structure is sized too large for percutaneousdelivery to the bodily cavity when the structure is in the deployedconfiguration.

In some embodiments, various systems may include combinations andsubsets of the systems summarized above.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and a memory device systemcommunicatively connected to the data processing device system andstoring a program executable by the data processing device system. Thedata processing device system is configured by the program at least toacquire information stored in the memory device system and detect acondition, based at least upon an analysis of the acquired information.The condition indicates that some, but not all, of a respectiveelectrically conductive surface portion of each of at least a firstelectrode of one or more electrodes is available for contact with tissueof a tissue wall of a bodily cavity when a structure, on which each ofthe one or more electrodes is located, is positioned in the bodilycavity in a deployed configuration, the deployed configuration beingdifferent than a delivery configuration in which the structure is sizedfor percutaneous delivery to the bodily cavity. The entirety of therespective electrically conductive surface portion of each of at leastthe first electrode of the one or more electrodes is configured, inabsence of the condition, for contact with a contiguous surface portionof the tissue wall when the structure is positioned in the bodily cavityin the deployed configuration. For each respective electricallyconductive surface portion, energy is transmittable between therespective electrically conductive surface portion and the tissue wall,the energy sufficient for tissue ablation. The data processing devicesystem is further configured by the program to store, in the memorydevice system, detection information indicating the detection of thecondition.

In some embodiments, a method is executed by a data processing devicesystem according to a program stored by a memory device systemcommunicatively connected to the data processing device system. Themethod may be summarized as including acquiring information stored inthe memory device system and detecting a condition, based at least uponan analysis of the acquired information. The condition indicates thatsome, but not all, of a respective electrically conductive surfaceportion of each of at least a first electrode of one or more electrodesis available for contact with tissue of a tissue wall of a bodily cavitywhen a structure, on which each of the one or more electrodes islocated, is positioned in the bodily cavity in a deployed configuration,the deployed configuration being different than a delivery configurationin which the structure is sized for percutaneous delivery to the bodilycavity. The entirety of the respective electrically conductive surfaceportion of each of at least the first electrode of the one or moreelectrodes is configured, in absence of the condition, for contact witha contiguous surface portion of the tissue wall when the structure ispositioned in the bodily cavity in the deployed configuration, and foreach respective electrically conductive surface portion, energy istransmittable between the respective electrically conductive surfaceportion and the tissue wall, the energy sufficient for tissue ablation.The method further includes storing, in the memory device system,detection information indicating the detection of the condition.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system. The program includes an acquisitionmodule configured to cause an acquisition of information stored in amemory device system and a detection module configured to cause adetection of a condition, based at least upon an analysis of theinformation acquired according to the acquisition module. The conditionindicates that some, but not all, of a respective electricallyconductive surface portion of each of at least a first electrode of oneor more electrodes is available for contact with tissue of a tissue wallof a bodily cavity when a structure, on which each of the one or moreelectrodes is located, is positioned in the bodily cavity in a deployedconfiguration, the deployed configuration being different than adelivery configuration in which the structure is sized for percutaneousdelivery to the bodily cavity. The entirety of the respectiveelectrically conductive surface portion of each of at least the firstelectrode of the one or more electrodes is configured, in absence of thecondition, for contact with a contiguous surface portion of the tissuewall when the structure is positioned in the bodily cavity in thedeployed configuration, and for each respective electrically conductivesurface portion, energy is transmittable between the respectiveelectrically conductive surface portion and the tissue wall, the energysufficient for tissue ablation. The program further includes a storagemodule configured to cause a storage in the memory device system ofdetection information indicating the detection of the conditionaccording to the detection module. In some embodiments, thecomputer-readable storage medium system is a non-transitorycomputer-readable storage medium system that includes one or morenon-transitory computer-readable storage mediums.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and a memory device systemcommunicatively connected to the data processing device system andstoring a program executable by the data processing device system. Theprogram includes acquisition instructions configured to cause anacquisition of information stored in the memory device system anddetection instructions configured to cause a detection of a condition,based at least upon an analysis of the information acquired according tothe acquisition instructions. The condition indicates that a distancebetween a first non-tissue based electrically conductive surfacepositioned in a bodily cavity and a first electrode located on astructure positioned in the bodily cavity in a deployed configuration isless than a target distance between the first non-tissue basedelectrically conductive surface and the first electrode when thestructure is in the deployed configuration, the deployed configurationbeing different than a delivery configuration in which the structure issized for percutaneous delivery to the bodily cavity. When the structureis positioned in the bodily cavity in the deployed configuration, energysufficient for tissue ablation is transmittable by the first electrode,at least some of the energy transmittable to adjacent tissue of a tissuewall of the bodily cavity. The program further includes storageinstructions configured to cause a storage in the memory device systemof detection information indicating the detection of the conditionaccording to the detection instructions.

In some embodiments, the medical device system further includes anelectrode-based device system that includes the first electrode and thestructure. In some embodiments, the medical device system includes thefirst non-tissue based electrically conductive surface.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including a sensing device system. Theprogram may further include reception instructions configured to cause(a) a reception of first information from the sensing device system, and(b) a storage of the first information or a derivative thereof in thememory device system, and the information acquired according to theacquisition instructions may be the first information or the derivativeof the first information stored in the memory device system according tothe reception instructions.

The medical device system may further include an input-output devicesystem communicatively connected to the data processing device system,the input-output device system including an electrode-based devicesystem that that includes the first electrode and the structure. Theprogram may further include reception instructions configured to cause(a) a reception of first information from the electrode-based devicesystem, and (b) a storage of the first information or a derivativethereof in the memory device system, and the information acquiredaccording to the acquisition instructions may be the first informationor the derivative of the first information stored in the memory devicesystem according to the reception instructions. The electrode-baseddevice system may include one or more transducers, the one or moretransducers configured to, while positioned in the bodily cavity,provide one or more electrical signals to the tissue wall. The firstinformation or the derivative thereof may indicate a result of aninteraction between the one or more electrical signals and the tissuewall, and the one or more electrical signals may include one or moreenergy levels insufficient for tissue ablation. In some embodiments, thefirst information or the derivative thereof is indicative of anelectrical impedance between the first electrode and a second non-tissuebased electrically conductive surface other than the first non-tissuebased electrically conductive surface, the electrical impedance beinglower than a target electrical impedance between the first electrode andthe second non-tissue based electrically conductive surface. The targetelectrical impedance may be associated with an occurrence in which thefirst electrode and the first non-tissue based electrically conductivesurface are spaced with respect to one another by the target distancewhen the structure is in the deployed configuration. In someembodiments, the first non-tissue based electrically conductive surfaceis part of a portion of the structure, and the second non-tissue basedelectrically conductive surface is part of a second electrode other thanthe first electrode. The second electrode may be an indifferentelectrode configured to be positioned outside of the bodily cavity. Thesecond electrode may be located on the structure.

In some embodiments, the first non-tissue based electrically conductivesurface is part of a second electrode other than the first electrode.The second electrode may be located on the structure. The secondnon-tissue based electrically conductive surface may be part of anindifferent electrode configured to be positioned outside of the bodilycavity. The second non-tissue based electrically conductive surface maybe part of a non-electrode portion of the structure. The secondnon-tissue based electrically conductive surface may be part of a thirdelectrode located on the structure, the third electrode being other thaneach of the first electrode and the second electrode.

In some embodiments, the structure includes a plurality of elongatemembers, and electrode-based device system includes a plurality ofelectrodes that include the first electrode, at least some of theplurality of the electrodes located on each of the plurality of elongatemembers. The first electrode may be located on a first elongate memberof the plurality of elongate members, and the first non-tissue basedelectrically conductive surface may be part of a second elongate memberof the plurality of elongate members, the second elongate member beingother than the first elongate member. In some embodiments, the structureincludes one or more elongate members, and the electrode-based devicesystem includes a plurality of electrodes that include the firstelectrode, at least some of the plurality of the electrodes located oneach of the one or more elongate members. The first electrode may belocated on a first elongate member of the one or more elongate members,and the first non-tissue based electrically conductive surface may bepart of a second electrode of the plurality of electrodes, the secondelectrode located on an elongate member of the one or more elongatemembers, the second electrode being other than the first electrode. Thesecond non-tissue based electrically conductive surface may be part ofan indifferent electrode configured to be positioned outside of thebodily cavity.

The bodily cavity may be an intra-cardiac cavity, and at least some ofthe energy being transmittable to blood in the intra-cardiac cavity. Thetarget distance may be determined to be sufficient to limit the at leastsome of the energy transmittable to the blood to have a magnitudeinsufficient for thermal coagulation of the blood.

The program may further include restriction instructions configured tocause a restriction of the energy transmittable by at least the firstelectrode in response to the detected condition. The medical devicesystem may further include an input-output device system communicativelyconnected to the data processing device system, and the program mayfurther include failure state instructions configured to cause theinput-output device system to present an error notification to a user inresponse to the detection of the condition according to the detectioninstructions. In some embodiments, the structure is sized too large forpercutaneous delivery to the bodily cavity when the structure is in thedeployed configuration.

In some embodiments, various systems may include combinations andsubsets of the systems summarized above.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and a memory device systemcommunicatively connected to the data processing device system andstoring a program executable by the data processing device system. Theprocessing device system is configured by the program at least toacquire information stored in the memory device system and detect acondition, based at least upon an analysis of the acquired information.The condition indicates that a distance between a first non-tissue basedelectrically conductive surface positioned in a bodily cavity and afirst electrode located on a structure positioned in the bodily cavityin a deployed configuration is less than a target distance between thefirst non-tissue based electrically conductive surface and the firstelectrode when the structure is in the deployed configuration, thedeployed configuration being different than a delivery configuration inwhich the structure is sized for percutaneous delivery to the bodilycavity. When the structure is positioned in the bodily cavity in thedeployed configuration, energy sufficient for tissue ablation istransmittable by the first electrode, at least some of the energytransmittable to adjacent tissue of a tissue wall of the bodily cavity.The processing device system is further configured by the program tostore, in the memory device system, detection information indicating thedetection of the condition.

In some embodiments, a method is executed by a data processing devicesystem according to a program stored by a memory device systemcommunicatively connected to the data processing device system. Themethod may be summarized as including acquiring information stored inthe memory device system and detecting a condition, based at least uponan analysis of the acquired information. The condition indicates that adistance between a first non-tissue based electrically conductivesurface positioned in a bodily cavity and a first electrode located on astructure positioned in the bodily cavity in a deployed configuration isless than a target distance between the first non-tissue basedelectrically conductive surface and the first electrode when thestructure is in the deployed configuration, the deployed configurationbeing different than a delivery configuration in which the structure issized for percutaneous delivery to the bodily cavity. When the structureis positioned in the bodily cavity in the deployed configuration, energysufficient for tissue ablation is transmittable by the first electrode,at least some of the energy transmittable to adjacent tissue of a tissuewall of the bodily cavity. The method further includes storing, in thememory device system, detection information indicating the detection ofthe condition.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system. The program includes an acquisitionmodule configured to cause an acquisition of information stored in amemory device system and a detection module configured to cause adetection of a condition, based at least upon an analysis of theinformation acquired according to the acquisition module. The conditionindicates that a distance between a first non-tissue based electricallyconductive surface positioned in a bodily cavity and a first electrodelocated on a structure positioned in the bodily cavity in a deployedconfiguration is less than a target distance between the firstnon-tissue based electrically conductive surface and the first electrodewhen the structure is in the deployed configuration, the deployedconfiguration being different than a delivery configuration in which thestructure is sized for percutaneous delivery to the bodily cavity. Whenthe structure is positioned in the bodily cavity in the deployedconfiguration, energy sufficient for tissue ablation is transmittable bythe first electrode, at least some of the energy transmittable toadjacent tissue of a tissue wall of the bodily cavity. The programfurther includes a storage module configured to cause a storage in thememory device system of detection information indicating the detectionof the condition according to the detection module. In some embodiments,the computer-readable storage medium system is a non-transitorycomputer-readable storage medium system that includes one or morenon-transitory computer-readable storage mediums.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and an input-output devicesystem communicatively connected to the data processing device system.The input-output device system includes an electrode-based device systemand a sensing device system, a first electrode of theelectrode-based-device system located on a structure of theelectrode-based device system. The structure is selectively moveablebetween a delivery configuration in which the structure is sized forpercutaneous delivery to a bodily cavity defined at least in part by atissue wall and a deployed configuration in which at least the firstelectrode is positioned in the bodily cavity. The medical device systemfurther includes a memory device system communicatively connected to thedata processing device system and storing a program executable by thedata processing device system. The program includes proximity detectioninstructions configured to cause a detection of a proximity conditionbased at least on an analysis of first information provided by orderived from information provided by the sensing device system. Theproximity condition indicates a proximity between a first non-tissuebased electrically conductive surface positioned in the bodily cavityand the first electrode when the structure is positioned in the bodilycavity in the deployed configuration. The first information isindicative of, when the structure is positioned in the bodily cavity inthe deployed configuration, an electrical impedance between (a) eitherthe first electrode or the first-non-tissue based electricallyconductive surface and (b) a second non-tissue based electricallyconductive surface. The second non-tissue based electrically conductivesurface is other than the first non-tissue based electrically conductivesurface, and the second non-tissue based electrically conductive surfacedoes not form part of the first electrode.

The electrical impedance may be between the first electrode and thesecond non-tissue based electrically conductive surface. The secondnon-tissue based electrically conductive surface may be part of anindifferent electrode configured to be positioned outside of the bodilycavity. The electrode-based device system may include a plurality ofelectrodes that include the first electrode and at least a secondelectrode, and the second non-tissue based electrically conductivesurface may form part of the second electrode. The second electrode maybe located on the structure.

The analysis may include an analysis of a combination of the firstinformation and second information, the second information provided byor derived from information provided by the sensing device system, andthe second information may be indicative of an amount of contact betweenthe first electrode and tissue of the tissue wall. An interior surfaceof the tissue wall may be interrupted by at least one port in fluidcommunication with the bodily cavity, and the second information mayinclude fluid flow information indicative of fluid flow at leastproximate the first electrode. The bodily cavity may be an intra-cardiaccavity, and the fluid flow information may be indicative of blood flowat least proximate the first electrode. The bodily cavity may be anintra-cardiac cavity, and the second information may include convectiveheat information indicative of convective heat transfer caused by bloodflow at least proximate the first electrode. The second information mayinclude temperature information determined at a location at leastproximate the first electrode.

The first non-tissue based electrically conductive surface may be partof a portion of the structure, and the second non-tissue basedelectrically conductive surface may be part of a second electrode otherthan the first electrode. The second electrode may be an indifferentelectrode configured to be positioned outside of the bodily cavity. Thesecond electrode may be located on the structure.

The first non-tissue based electrically conductive surface may be partof a second electrode other than the first electrode. The secondelectrode may be located on the structure. The second non-tissue basedelectrically conductive surface may be part of an indifferent electrodeconfigured to be positioned outside of the bodily cavity. The secondnon-tissue based electrically conductive surface may be part of anon-electrode portion of the structure. The second non-tissue basedelectrically conductive surface may be part of a third electrode locatedon the structure, the third electrode other than each of the firstelectrode and the second electrode.

The structure may include a plurality of elongate members, and theelectrode-based device system may include a plurality of electrodes thatinclude the first electrode, at least some of the plurality of theelectrodes located on each of the plurality of elongate members. Thefirst electrode may be located on a first elongate member of theplurality of elongate members, and the first non-tissue basedelectrically conductive surface may be part of a second elongate memberof the plurality of elongate members, the second elongate member beingother than the first elongate member. The second non-tissue basedelectrically conductive surface may be part of an indifferent electrodeconfigured to be positioned outside of the bodily cavity.

The structure may include one or more elongate members, and theelectrode-based device system may include a plurality of electrodes thatinclude the first electrode, at least some of the plurality of theelectrodes located on each of the one or more elongate members. Thefirst electrode may be located on a first elongate member of the one ormore elongate members, and the first non-tissue based electricallyconductive surface may be part of a second electrode of the plurality ofelectrodes, the second electrode located on an elongate member of theone or more elongate members, the second electrode being other than thefirst electrode. The second non-tissue based electrically conductivesurface may be part of an indifferent electrode configured to bepositioned outside of the bodily cavity.

The structure may be sized too large for percutaneous delivery to thebodily cavity in the deployed configuration. When the structure ispositioned in the bodily cavity in the deployed configuration, energysufficient for tissue ablation may be transmittable by the firstelectrode. The sensing device system may form at least part of theelectrode-based device system.

The proximity condition may indicate a proximity between the firstnon-tissue based electrically conductive surface positioned in thebodily cavity and the first electrode when the first non-tissue basedelectrically conductive surface, the first electrode or each of thefirst non-tissue based electrically conductive surface and the firstelectrode contacts a surface of the tissue wall. The first informationmay be indicative of the electrical impedance when the first non-tissuebased electrically conductive surface, the first electrode or each ofthe first non-tissue based electrically conductive surface and the firstelectrode contacts a surface of the tissue wall.

In some embodiments, various systems may include combinations andsubsets of the systems summarized above.

In some embodiments, a medical device system may be summarized asincluding a data processing device system and an input-output devicesystem communicatively connected to the data processing device system.The input-output device system includes an electrode-based device systemand a sensing device system. A first electrode of theelectrode-based-device system is located on a structure of theelectrode-based device system, the structure selectively moveablebetween a delivery configuration in which the structure is sized forpercutaneous delivery to a bodily cavity defined at least in part by atissue wall and a deployed configuration in which at least the firstelectrode is positioned in the bodily cavity. The medical device systemfurther includes a memory device system communicatively connected to thedata processing device system and storing a program executable by thedata processing device system. The data processing device system isconfigured by the program at least to detect a proximity condition basedat least on an analysis of first information provided by or derived frominformation provided by the sensing device system, the proximitycondition indicating a proximity between a first non-tissue basedelectrically conductive surface positioned in the bodily cavity and thefirst electrode when the structure is positioned in the bodily cavity inthe deployed configuration. The first information is indicative of, whenthe structure is positioned in the bodily cavity in the deployedconfiguration, an electrical impedance between (a) either the firstelectrode or the first-non-tissue based electrically conductive surfaceand (b) a second non-tissue based electrically conductive surface. Thesecond non-tissue based electrically conductive surface is other thanthe first non-tissue based electrically conductive surface, and thesecond non-tissue based electrically conductive surface does not formpart of the first electrode.

In some embodiments, a method is executed by a data processing devicesystem according to a program stored by a memory device systemcommunicatively connected to the data processing device system. The dataprocessing device system is communicatively connected to an input-outputdevice system, the input-output device system including anelectrode-based device system and a sensing device system. A firstelectrode of the electrode-based-device system is located on a structureof the electrode-based device system, the structure selectively moveablebetween a delivery configuration in which the structure is sized forpercutaneous delivery to a bodily cavity defined at least in part by atissue wall and a deployed configuration in which at least the firstelectrode is positioned in the bodily cavity. The method may besummarized as including detecting a proximity condition based at leaston an analysis of first information provided by or derived frominformation provided by the sensing device system, the proximitycondition indicating a proximity between a first non-tissue basedelectrically conductive surface positioned in the bodily cavity and thefirst electrode when the structure is positioned in the bodily cavity inthe deployed configuration. The first information is indicative of, whenthe structure is positioned in the bodily cavity in the deployedconfiguration, an electrical impedance between (a) either the firstelectrode or the first non-tissue based electrically conductive surfaceand (b) a second non-tissue based electrically conductive surface. Thesecond non-tissue based electrically conductive surface is other thanthe first non-tissue based electrically conductive surface, and thesecond non-tissue based electrically conductive surface does not formpart of the first electrode.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system communicatively connected to aninput-output device system, the input-output device system including anelectrode-based device system and a sensing device system. A firstelectrode of the electrode-based-device system is located on a structureof the electrode-based device system, the structure selectively moveablebetween a delivery configuration in which the structure is sized forpercutaneous delivery to a bodily cavity defined at least in part by atissue wall and a deployed configuration in which at least the firstelectrode is positioned in the bodily cavity. The program includes aproximity detection module configured to cause a detection of aproximity condition based at least on an analysis of first informationprovided by or derived from information provided by the sensing devicesystem, the proximity condition indicating a proximity between a firstnon-tissue based electrically conductive surface positioned in thebodily cavity and the first electrode when the structure is positionedin the bodily cavity in the deployed configuration. The firstinformation is indicative of, when the structure is positioned in thebodily cavity in the deployed configuration, an electrical impedancebetween (a) either the first electrode or the first-non-tissue basedelectrically conductive surface and (b) a second non-tissue basedelectrically conductive surface. The second non-tissue basedelectrically conductive surface is other than the first non-tissue basedelectrically conductive surface, and the second non-tissue basedelectrically conductive surface does not form part of the firstelectrode. In some embodiments, the computer-readable storage mediumsystem is a non-transitory computer-readable storage medium system thatincludes one or more non-transitory computer-readable storage mediums.

Various systems may include combinations and subsets of all the systemssummarized above.

Various methods may include combinations and subsets of all the methodssummarized above. In addition, a computer program product may beprovided that comprises program code portions for performing some or allof any of the methods summarized above, when the computer programproduct is executed by a computing device. The computer program productmay be stored on one or more computer-readable storage mediums.

BRIEF DESCRIPTION OF THE DRAWINGS

It is to be understood that the attached drawings are for purposes ofillustrating aspects of various embodiments and may include elementsthat are not to scale.

FIG. 1 is a schematic representation of a medical device systemaccording to various example embodiments, where the medical devicesystem may include a data processing device system, an input-outputdevice system, and a memory device system, according to someembodiments.

FIG. 2 is a cutaway diagram of a heart showing an electrode-based devicesystem percutaneously placed in a left atrium of the heart according tovarious example embodiments, the electrode-based device systemoptionally being part of the input-output device system of FIG. 1,according to some embodiments.

FIG. 3A is a partially schematic representation of a medical devicesystem, which may represent one or more implementations of the medicaldevice system of FIG. 1 in which an expandable structure of anelectrode-based device system is in a delivery or unexpandedconfiguration, according to various example embodiments.

FIG. 3B is the representation of the medical device system of FIG. 3Awith the expandable structure shown in a deployed or expandedconfiguration, according to some embodiments.

FIG. 3C is a representation of the expandable structure of the medicaldevice system of FIG. 3A in the deployed or expanded configuration, asviewed from a different viewing angle than that employed in FIG. 3B,according to some embodiments.

FIG. 3D is a plan view of the expandable structure of FIG. 3C, accordingto some embodiments.

FIG. 3E is the plan view of FIG. 3D but with an improper positioningbetween various members of the structure, according to some embodiments.

FIG. 4 illustrates a schematic representation of an electrode-baseddevice that includes a flexible circuit structure, according to variousexample embodiments.

FIG. 5 is a block diagram of a method employed in various embodiments,the method including detecting one or more particular conditionsassociated with at least one electrode of an electrode-based devicesystem, according to some embodiments.

FIG. 5A is an exploded view of some of the blocks of the block diagramof FIG. 5 according to some example embodiments, some of the explodedblocks associated with a detection of a condition indicating a deviationfrom an expected positioning of at least a portion of an electrode-baseddevice system, according to some embodiments.

FIG. 5B is an exploded view of a block of the block diagram of FIG. 5according to some example embodiments, the exploded block associatedwith a detection of a condition indicating that some, but not all, of anelectrically conductive surface portion of a first electrode isavailable for contact with tissue of a tissue wall, according to someembodiments.

FIG. 5C is an exploded view of a block of the block diagram of FIG. 5according to some example embodiments, the exploded block associatedwith a detection of a condition indicating contact between a non-tissuebased surface and an electrically conductive surface portion of a firstelectrode, according to some embodiments.

FIG. 5D is an exploded view of a block of the block diagram of FIG. 5according to some example embodiments, the exploded block associatedwith a detection of a shunt condition, according to some embodiments.

FIG. 5E is an exploded view of a portion of the block diagram of FIG. 5according to some example embodiments, the exploded view associated witha determination of a deviation in an expected position between a firstelectrode and a physical portion of an electrode-based device systembased at least on a detected shunt condition, according to someembodiments.

FIG. 5F is an exploded view of a block of the block diagram of FIG. 5according to some example embodiments, the exploded block associatedwith a detection of a condition indicating that a distance between afirst non-tissue based electrically conductive surface and a firstelectrode is less than a target distance, according to some embodiments.

FIG. 5G is an exploded view of some of the blocks of the block diagramof FIG. 5 according to some example embodiments, the exploded blocksassociated with a detection of a proximity condition indicating aproximity between a first non-tissue based electrically conductivesurface and a first electrode, according to some embodiments.

FIG. 6A is a schematic cross sectional view, according to variousexample embodiments, of a first electrode positioned adjacent tissue ofa tissue wall that defines, at least in part, a bodily cavity, energytransmittable from the first electrode flowing along a first electricalpath, according to some embodiments.

FIG. 6B is a top view of at least the first electrode and tissue wall ofFIG. 6A, according to some embodiments.

FIG. 6C illustrates a shunt condition associated with a diversion of aportion of energy transmittable by the first electrode of FIG. 6A fromthe first electrical path to a second electrical path different than thefirst electrical path, according to some embodiments.

FIG. 6D is a top view of at least the first electrode and tissue wall ofFIG. 6C, according to some embodiments.

FIG. 6E is a schematic cross sectional view, according to variousexample embodiments, of a first electrode positioned adjacent tissue ofa tissue wall that defines, at least in part, a bodily cavity, energytransmittable from the first electrode flowing along a first electricalpath to a second electrode positioned in the bodily cavity, according tosome embodiments.

FIG. 6F illustrates a shunt condition associated with a diversion of aportion of energy transmittable by the first electrode of FIG. 6E fromthe first electrical path to a second electrical path different than thefirst electrical path, according to some embodiments.

FIG. 6G is a schematic cross sectional view, according to variousexample embodiments, of a first electrode positioned adjacent tissue ofa tissue wall that defines a bodily cavity, energy transmittable fromthe first electrode flowing along a first electrical path, according tosome embodiments.

FIG. 6H illustrates a shunt condition associated with a diversion of aportion of energy transmittable by the first electrode of FIG. 6G fromthe first electrical path to a second electrical path different than thefirst electrical path, according to some embodiments.

FIG. 6I is a top view of at least the first electrode and tissue wall ofFIG. 6H, according to some embodiments.

FIG. 7 is a block diagram of an electric circuit configured to determinean electrical impedance between various objects, according to someembodiments.

FIG. 8 is a block diagram of an electrical circuit configured todetermine an electrical resistance of various resistive members employedby various transducer elements, according to some example embodiments.

FIG. 9 illustrates various graphs of electrical impedance as a functionof a spacing between a first electrode and a first non-tissue basedelectrically conductive surface, according to some embodiments.

DETAILED DESCRIPTION

Some embodiments of the present invention pertain to the detection ofconditions where energy intended to be transmitted or delivered to onelocation could instead be delivered to another location. Although suchconditions may arise in other contexts, they may be particularlyimportant in medical device systems where consequences of an improperenergy transmission or delivery configuration might be associated withelevated risk. For example, in procedures configured to treat atrialfibrillation, ablative energy is intended to be delivered to tissueforming an interior cavity of a heart by way of one or more electrodes.Often times, an intended operational state of an ablation deviceincluding such one or more electrodes is to have such electrode(s)contact or at least be available (e.g., without some obstruction) forcontact with the tissue forming the interior cavity of the heart so thatablative energy may be transferred to such tissue in order to form alesion that blocks or contains (e.g., surrounds) the spurious electricalsignals causing the fibrillation. However, if an electrode isinadvertently too close to another conductive portion of the ablationdevice, it is possible that at least a portion of ablative energydelivered by the electrode will travel towards that other conductiveportion of the ablation device and not reach its intended target, anintended portion of the tissue. Such a circumstance can lead tounintended energy being delivered elsewhere to the patient. In thisregard, some embodiments of the present invention facilitate detectionof at least some of these unintended circumstances so that they can beavoided. However, it can be seen that various embodiments of the presentinvention are not limited to intra-cardiac medical devices or evenmedical devices more generally and, instead, have broader applicability.

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various embodiments of theinvention. However, one skilled in the art will understand that theinvention may be practiced without these details. In other instances,well-known structures have not been shown or described in detail toavoid unnecessarily obscuring descriptions of various embodiments of theinvention.

Reference throughout this specification to “one embodiment” or “anembodiment” or “an example embodiment” or “an illustrated embodiment” or“a particular embodiment” and the like means that a particular feature,structure or characteristic described in connection with the embodimentis included in at least one embodiment. Thus, the appearances of thephrases “in one embodiment” or “in an embodiment” or “in an exampleembodiment” or “in this illustrated embodiment” or “in this particularembodiment” and the like in various places throughout this disclosureare not necessarily all referring to one embodiment or a sameembodiment. Furthermore, the particular features, structures orcharacteristics of different embodiments may be combined in any suitablemanner to form one or more other embodiments.

Unless otherwise explicitly noted or required by context, the word “or”is used in this disclosure in a non-exclusive sense. In addition, unlessotherwise explicitly noted or required by context, the word “set” isintended to mean one or more. For example, the phrase, “a set ofobjects” means one or more of the objects. In addition, unless otherwiseexplicitly noted or required by context, the word “subset” is intendedto mean a set having the same or fewer elements of those present in thesubset's parent or superset.

Further, the phrase “at least” is used herein at times to emphasize thepossibility that other elements can exist besides those explicitlylisted. However, unless otherwise explicitly noted (such as by the useof the term “only”) or required by context, non-usage herein of thephrase “at least” includes the possibility that other elements existbesides those explicitly listed. For example, the phrase, ‘based atleast upon A’ includes A, as well as the possibility of one or moreother additional elements besides A. In the same manner, for example,the phrase, ‘based upon A’ includes A, as well as the possibility of oneor more other additional elements besides A. However, for example, thephrase, ‘based only upon A’ includes only A.

The word “fluid” as used in this disclosure should be understood toinclude any fluid that can be contained within a bodily cavity or canflow into or out of, or both into and out of a bodily cavity via one ormore bodily openings positioned in fluid communication with the bodilycavity. In some embodiments, the word “fluid” may include fluid that isnot inherent to the bodily cavity, such as saline or other fluid thatmight artificially introduced into the bodily cavity. In the case ofcardiac applications, fluid such as blood will flow into and out ofvarious intra-cardiac cavities (e.g., a left atrium or right atrium).

The phrase “bodily opening” as used in this disclosure should beunderstood to include a naturally occurring bodily opening or channel orlumen; a bodily opening or channel or lumen formed by an instrument ortool using techniques that can include, but are not limited to,mechanical, thermal, electrical, chemical, and exposure or illuminationtechniques; a bodily opening or channel or lumen formed by trauma to abody; or various combinations of one or more of the above or otherbodily openings. Various elements having respective openings, lumens orchannels and positioned within the bodily opening (e.g., a cathetersheath) may be present in various embodiments. These elements mayprovide a passageway through a bodily opening for various devicesemployed in various embodiments.

The words “bodily cavity” as used in this disclosure should beunderstood to mean a cavity in a body. The bodily cavity may be a cavityprovided in a bodily organ (e.g., an intra-cardiac cavity of a heart).

The word “tissue” often is used in this disclosure, and tissue mayinclude non-fluidic tissue and fluidic tissue. Non-fluidic tissuegenerally (or predominantly) has solid-like properties, such as tissuethat forms a surface of a body or a surface within a bodily cavity, asurface of an anatomical feature or a surface of a feature associatedwith a bodily opening positioned in fluid communication with the bodilycavity. Non-fluidic tissue can include part or all of a tissue wall ormembrane that defines a surface of the bodily cavity. In this regard,the tissue can form an interior surface of the cavity that at leastpartially surrounds a fluid within the cavity. In the case of cardiacapplications, non-fluidic tissue can include tissue used to form aninterior surface of an intra-cardiac cavity such as a left atrium orright atrium. Fluidic tissue, on the other hand, generally (orpredominantly) has fluid-like properties (as compared to solid-likeproperties). An example of fluidic tissue is blood. In this regard, itshould be noted that fluidic tissue can have some solid-likecomponent(s) (e.g., non-fluidic tissue may include solid-likecomponents), and non-fluidic tissue can have some fluid-likecomponent(s) (e.g, non-fluidic tissue may include fluidic tissue withinit). Unless otherwise explicitly noted or required by context, the word“tissue” should include non-fluidic tissue and fluidic tissue. However,some contexts where the word “tissue” would not include fluidic tissueare when tissue ablation is discussed, and ablation of fluidic tissuecould be undesired, as discussed below.

The word “ablation” as used in this disclosure should be understood toinclude any disruption to certain properties of tissue. Most commonly,the disruption is to the electrical conductivity of tissue and may beachieved by heating, which can be generated with resistive orradio-frequency (RF) techniques for example. Other properties of tissue,such as mechanical or chemical, and other means of disruption, such asoptical, are included when the term “ablation” is used. In someembodiments, systems are configured to perform ablation of non-fluidictissue while avoiding the delivery of excessive energy to fluidictissue, because energy that is sufficient to ablate non-fluidic tissuemay also impact fluidic tissue in some circumstances. For example,energy that is sufficient to ablate non-fluidic tissue, in somecircumstances, may cause blood (an example of fluidic tissue) tocoagulate. In these and other embodiments where ablative energytransferred to fluidic tissue is not desired, it should be understoodthat any statement or reference to the ‘ablation of tissue’ or the likein these contexts is intended to refer to ablation of non-fluidictissue, as opposed to ablation of fluidic tissue. Techniques, accordingto some embodiments disclosed herein, facilitate the detection ofconditions where energy that is intended to ablate non-fluidic tissuemight unintentionally be delivered to blood or another object.

The term “transducer” as used in this disclosure should be interpretedbroadly as any device capable at least of distinguishing between fluidand non-fluidic tissue, sensing temperature, creating heat, ablatingtissue and measuring electrical activity of a tissue surface,stimulating tissue or any combination thereof. A transducer can convertinput energy of one form into output energy of another form. Withoutlimitation, a transducer can include an electrode, and references to a“transducer” herein can be replaced with “electrode” according to someembodiments. Without limitation, a transducer can include an electrodeor a sensing device, or both an electrode and a sensing device. Anelectrode, in some embodiments, can be configured at least as a sensingdevice. Because a transducer can include an electrode according tovarious embodiments, any reference herein to a transducer may also implya reference to an electrode, or vice versa. A transducer may beconstructed from several parts, which may be discrete components or maybe integrally formed.

The term “activation” should be interpreted broadly as making active aparticular function as related to various transducers such as thosedisclosed herein, for example. Particular functions can include, but arenot limited to, tissue ablation, sensing electrophysiological activity,sensing temperature and sensing electrical characteristics (e.g., tissueimpedance). For example, in some embodiments, activation of a tissueablation function of a particular transducer is initiated by causingenergy sufficient for tissue ablation from an energy source devicesystem to be delivered to the particular transducer. In someembodiments, activation of a tissue ablation function of a particularelectrode is initiated by causing energy from an energy source devicesystem to be delivered to the particular electrode, the energysufficient for tissue ablation. In some embodiments, activation of atissue ablation function of a particular electrode is initiated bycausing energy sufficient for tissue ablation to be transmitted by theparticular electrode. Alternatively, in some embodiments, the activationcan be deemed to be initiated when the particular transducer orparticular electrode causes tissue that is to be ablated to reach oracquire a temperature sufficient for ablation of the tissue, which maybe due to the energy provided by the energy source device system or dueto the energy transmitted by the particular transducer or electrode. Insome embodiments, the activation can last for a duration concluding whenthe ablation function is no longer active, such as when energysufficient for the tissue ablation is no longer provided to, ortransmitted by, the particular transducer or particular electrode.Alternatively, in some embodiments, the activation period can be deemedto be concluded when the tissue that is being ablated has a temperaturebelow that sufficient for ablation of the tissue, which may be due to areduction or cessation of the energy provided by the energy sourcedevice system or transmitted by the particular transducer or electrode.In some contexts, however, the word “activation” can merely refer to theinitiation of the activating of a particular function, as opposed toreferring to both the initiation of the activating of the particularfunction and the subsequent duration in which the particular function isactive. In these contexts, the phrase or a phrase similar to “activationinitiation” may be used.

The term “program” in this disclosure should be interpreted as a set ofinstructions or modules that can be executed by one or more componentsin a system, such as a controller system or data processing devicesystem, in order to cause the system to perform one or more operations.The set of instructions or modules can be stored by any kind of memorydevice, such as those described subsequently with respect to the memorydevice system 130 shown in FIG. 1. In addition, it may be described thatthe instructions or modules of a program are configured to cause theperformance of a function. The phrase “configured to” in this context isintended to include at least (a) instructions or modules that arepresently in a form executable by one or more data processing devices tocause performance of the function (e.g., in the case where theinstructions or modules are in a compiled and unencrypted form ready forexecution), and (b) instructions or modules that are presently in a formnot executable by the one or more data processing devices, but could betranslated into the form executable by the one or more data processingdevices to cause performance of the function (e.g., in the case wherethe instructions or modules are encrypted in a non-executable manner,but through performance of a decryption process, would be translatedinto a form ready for execution). The word “module” can be defined as aset of instructions.

Further, it is understood that information or data may be operated upon,manipulated, or converted into different forms as it moves throughvarious devices or workflows. In this regard, unless otherwiseexplicitly noted or required by context, it is intended that anyreference herein to information or data includes modifications to thatinformation or data. For example, “data X” may be encrypted fortransmission, and a reference to “data X” is intended to include bothits encrypted and unencrypted forms. For another example, “imageinformation Y” may undergo a noise filtering process, and a reference to“image information Y” is intended to include both the pre-processed formand the noise-filtered form. In other words, both the pre-processed formand the noise-filtered form are considered to be “image information Y”.In order to stress this point, the phrase “or a derivative thereof” orthe like may be used herein. Continuing the preceding example, thephrase “image information Y or a derivative thereof” refers to both thepre-processed form and the noise-filtered form of “image information Y”,with the noise-filtered form potentially being considered a derivativeof “image information Y”. However, non-usage of the phrase “or aderivative thereof” or the like nonetheless includes derivatives ormodifications of information or data just as usage of such a phrasedoes, as such a phrase, when used, is merely used for emphasis.

The word “device” and the phrase “device system” both are intended toinclude one or more physical devices or sub-devices (e.g., pieces ofequipment) that interact to perform one or more functions, regardless ofwhether such devices or sub-devices are located within a same housing ordifferent housings. In this regard, for example, the phrase“electrode-based device” could equivalently be referred to as an“electrode-based device system”.

In some contexts, the term “adjacent” may be used to refer to objectsthat do not have another substantially similar object between them. Forexample, object A and object B could be considered adjacent if theycontact each other (and, thus, it could be considered that no otherobject is between them), or if they do not contact each other but noother object that is substantially similar to object A, object B, orboth objects A and B, depending on context, is between them. In somecontexts, the term “adjacent” additionally refers to at least asufficient proximity between the objects defined as adjacent to allowthe objects to interact in a designated way. For example, if object Aperforms an action on an adjacent object B, objects A and B would haveat least a sufficient proximity to allow object A to perform the actionon the object B. In this regard, some actions may require contactbetween the associated objects, such that if object A performs such anaction on an adjacent object B, objects A and B would be in contact.

Further, the phrase “in response to” may be used in a context where anevent A occurs in response to the occurrence of an event B. In thisregard, such phrase can include, for example, that at least theoccurrence of the event B causes or triggers the event A.

In some contexts, the term “proximity” is used in this disclosure torefer to a degree of closeness between various objects. For example, aproximity between an object A and an object B could be considered tomean a degree of closeness of (a) object A to object B, (b) object B toobject A, or both (a) and (b). Such degree of closeness may includecontact in some embodiments.

Further still, example methods are described herein with respect toFIGS. 5, 5A, 5B, 5C, 5D, 5E, 5F, and 5G. Such figures are described toinclude blocks associated with instructions. It should be noted that therespective instructions associated with various method blocks herein,need not be separate instructions and may be combined with otherinstructions to form a combined instruction set. In this regard, theblocks shown in each of the method figures herein are not intended toillustrate an actual structure of any program or set of instructions,and such method figures, according to some embodiments, merelyillustrate the tasks or processes that instructions are configured toperform upon execution by a data processing device system in conjunctionwith interactions with one or more other devices or device systems.

FIG. 1 schematically illustrates a medical device system 100 accordingto some embodiments. Although the system 100 is described as a medicaldevice system 100, such system 100 is not limited thereto, and can beanother type of system, such as a system configured to detect one ormore improper energy transmission configurations in a system in whichenergy transmission is a priority. In this regard, such detecting of oneor more improper energy transmission configures can be important in,among other systems, medical device systems, where energy transmissionmay need to be properly controlled to successfully treat a patient in adesired manner.

In some embodiments, the medical device system 100 includes a dataprocessing device system 110, an input-output device system 120, and aprocessor-accessible memory device system 130. The processor-accessiblememory device system 130 and the input-output device system 120 arecommunicatively connected to the data processing device system 110.

The data processing device system 110 includes one or more dataprocessing devices that implement or execute, in conjunction with otherdevices, such as one or more of those in the system 100, the methods ofvarious embodiments, including the example methods of 5, 5A, 5B, 5C, 5D,5E, 5F, and 5G described herein. Each of the phrases “data processingdevice”, “data processor”, “processor”, and “computer” is intended toinclude any data processing device, such as a central processing unit(“CPU”), a desktop computer, a laptop computer, a mainframe computer, atablet computer, a personal digital assistant, a cellular phone, and anyother device configured to process data, manage data, or handle data,whether implemented with electrical, magnetic, optical, biologicalcomponents, or other.

The memory device system 130 includes one or more processor-accessiblememory devices configured to store information, including theinformation needed to execute the methods of various embodiments,including the example methods of FIGS. 5, 5A, 5B, 5C, 5D, 5E, 5F, and 5Gdescribed herein. The memory device system 130 may be a distributedprocessor-accessible memory device system including multipleprocessor-accessible memory devices communicatively connected to thedata processing device system 110 via a plurality of computers and/ordevices. On the other hand, the memory device system 130 need not be adistributed processor-accessible memory system and, consequently, mayinclude one or more processor-accessible memory devices located within asingle data processing device.

Each of the phrases “processor-accessible memory” and“processor-accessible memory device” is intended to include anyprocessor-accessible data storage device, whether volatile ornonvolatile, electronic, magnetic, optical, or otherwise, including butnot limited to, registers, floppy disks, hard disks, Compact Discs,DVDs, flash memories, ROMs, and RAMs. In some embodiments, each of thephrases “processor-accessible memory” and “processor-accessible memorydevice” is intended to include a non-transitory computer-readablestorage medium. In some embodiments, the memory device system 130 can beconsidered a non-transitory computer-readable storage medium system.

The phrase “communicatively connected” is intended to include any typeof connection, whether wired or wireless, between devices, dataprocessors, or programs in which data may be communicated. Further, thephrase “communicatively connected” is intended to include a connectionbetween devices or programs within a single data processor, a connectionbetween devices or programs located in different data processors, and aconnection between devices not located in data processors at all. Inthis regard, although the memory device system 130 is shown separatelyfrom the data processing device system 110 and the input-output devicesystem 120, one skilled in the art will appreciate that the memorydevice system 130 may be located completely or partially within the dataprocessing device system 110 or the input-output device system 120.Further in this regard, although the input-output device system 120 isshown separately from the data processing device system 110 and thememory device system 130, one skilled in the art will appreciate thatsuch system may be located completely or partially within the dataprocessing system 110 or the memory device system 130, depending uponthe contents of the input-output device system 120. Further still, thedata processing device system 110, the input-output device system 120,and the memory device system 130 may be located entirely within the samedevice or housing or may be separately located, but communicativelyconnected, among different devices or housings. In the case where thedata processing device system 110, the input-output device system 120,and the memory device system 130 are located within the same device, thesystem 100 of FIG. 1 can be implemented by a single application-specificintegrated circuit (ASIC) in some embodiments.

The input-output device system 120 may include a mouse, a keyboard, atouch screen, another computer, or any device or combination of devicesfrom which a desired selection, desired information, instructions, orany other data is input to the data processing device system 110. Theinput-output device system 120 may include a user-activatable controlsystem that is responsive to a user action, such as actions from a careprovider such as a physician or technician. The input-output devicesystem 120 may include any suitable interface for receiving information,instructions or any data from other devices and systems described invarious ones of the embodiments. In this regard, the input-output devicesystem 120 may include various ones of other systems described invarious embodiments. For example, the input-output device system 120 mayinclude at least a portion of a transducer-based device system or anelectrode-based device system. The phrase “transducer-based devicesystem” is intended to include one or more physical devices or systemsthat include various transducers. Similarly, the phrase “electrode-baseddevice system” is intended to include one or more physical devices orsystems that include various electrodes. In this regard, the phrases“transducer-based device system” and “electrode-based device system” maybe used interchangeably in accordance with various embodiments.Similarly, the phrases “transducer-based device” and “electrode-baseddevice” may be used interchangeably in accordance with variousembodiments.

The input-output device system 120 also may include an image generatingdevice system, a display device system, a speaker device system, aprocessor-accessible memory device system, or any device or combinationof devices to which information, instructions, or any other data isoutput from the data processing device system 110. In this regard, ifthe input-output device system 120 includes a processor-accessiblememory device, such memory device may or may not form part or all of thememory device system 130. The input-output device system 120 may includeany suitable interface for outputting information, instructions or datato other devices and systems described in various ones of theembodiments. In this regard, the input-output device system may includevarious other devices or systems described in various embodiments.

FIG. 2 shows an electrode-based device system 200, which may be includedin the input-output device system 120 of FIG. 1, according to someembodiments. Because, as described in more detail below with respect toFIG. 4, electrodes may be part of transducers, according to someembodiments, the system 200 may also be considered a transducer-baseddevice system in some embodiments.

Such a system 200 may be useful for, among other things, investigatingor treating a bodily organ, for example a heart 202, according to someexample embodiments. The electrode-based device system 200 can bepercutaneously or intravascularly inserted into a portion of the heart202, such as an intra-cardiac cavity like left atrium 204. In thisexample, the electrode-based device system 200 includes a catheter 206inserted via the inferior vena cava 208 and penetrating through a bodilyopening in transatrial septum 210 from right atrium 212. In otherembodiments, other paths may be taken.

Catheter 206 may include an elongated flexible rod or shaft memberappropriately sized to be delivered percutaneously or intravascularly.Various portions of catheter 206 may be steerable. Catheter 206 mayinclude one or more lumens (not shown). The lumen(s) may carry one ormore communications or power paths, or both. For example, the lumens(s)may carry one or more electrical conductors 216 (two shown in thisembodiment). Electrical conductors 216 provide electrical connectionsfor system 200 that are accessible externally from a patient in whichthe electrode-based device system 200 is inserted.

In some embodiments, the electrical conductors 216 may provideelectrical connections to transducers 220 (three called out in FIG. 2)that respectively include one or more electrodes, and optionally one ormore other devices, (e.g., both discussed with respect to FIG. 4, below)configured to, among other things, provide stimulation (e.g., electricalstimulation that may include pinging or pacing) to tissue within abodily cavity (e.g., left atrium 204), ablate tissue in a desiredpattern within the bodily cavity, sense characteristics of tissue (e.g.,electrophysiological activity, convective cooling, permittivity, force,temperature, impedance, thickness, or a combination thereof) within thebodily cavity, or a combination thereof.

The sensing of characteristics may, among other things, be configured todistinguish between fluid, such as fluidic tissue (e.g., blood), andnon-fluidic tissue forming an interior surface of a bodily cavity (e.g.,left atrium 204); may be configured to map the cavity, for example,using positions of openings or ports into and out of the cavity todetermine a position or orientation (e.g., pose), or both of a portionof the device system 200 in the bodily cavity; may be configured toindicate whether an ablation has been successful; or a combinationthereof.

Electrode-based device system 200 may include a frame or structure 218which assumes an unexpanded or delivery configuration (e.g., FIG. 3A,discussed below) for delivery to left atrium 204. Structure 218 isdeployed or expanded (i.e., shown in a deployed or expandedconfiguration in FIG. 2, as well as FIGS. 3B, 3C, and 3D, which arediscussed below) upon delivery to left atrium 204. In this regard, insome embodiments, the electrode-based device system 200 is moveablebetween a delivery or unexpanded configuration (e.g., FIG. 3A, discussedbelow) in which a portion (e.g., the structure 218) of the device system200 is sized for passage though a bodily opening leading to a bodilycavity, and a deployed or expanded configuration (e.g., FIG. 2, as wellas FIGS. 3B, 3C, and 3D discussed below) in which the portion of thedevice system 200 has a size too large for passage through the bodilyopening leading to the bodily cavity. An example of an expanded ordeployed configuration is when the portion of the electrode-based devicesystem is in its intended-deployed-operational state inside the bodilycavity. Another example of the expanded or deployed configuration iswhen the portion of the electrode-based device system is being changedfrom the delivery configuration to the intended-deployed-operationalstate to a point where the portion of the device system now has a sizetoo large for passage through the bodily opening leading to the bodilycavity. Further, in some embodiments, when the portion (e.g., thestructure 218) is in the expanded or deployed configuration in the leftatrium 204, various ones of a plurality of transducers 220 arepositioned proximate the interior surface formed by non-fluidic tissue222 of left atrium 204. In some embodiments, when the portion (e.g., thestructure 218) is in the expanded or deployed configuration in the leftatrium 204, various ones of plurality of transducers 220 are positionedsuch that a physical portion of each of the various ones of thetransducers 220 is configured to contact the interior surface formed bynon-fluidic tissue 222 of left atrium 204. In some embodiments, at leastsome of the transducers 220 are configured to sense a physicalcharacteristic of a fluid (i.e., blood), non-fluidic tissue 222, orboth, that may be used to determine a position or orientation (i.e.,pose), or both, of a portion of a device system 200 within, or withrespect to left atrium 204. For example, transducers 220 may beconfigured to determine a location of pulmonary vein ostia (not shown)or a mitral valve 226, or both. In some embodiments, at least some ofthe transducers 220 may be configured to selectively ablate portions ofthe non-fluidic tissue 222. For example, some of the transducers 220 maybe configured to ablate a pattern or path around various ones of thebodily openings, ports or pulmonary vein ostia, for instance, to reduceor eliminate the occurrence of atrial fibrillation. Each of various onesof the transducers 220 may include an electrode in various embodiments,as described below with respect to FIG. 4, for example.

Each of FIGS. 3A and 3B is a partially schematic representation of amedical device system, which may represent one or more implementationsof the medical device system 100 of FIG. 1, according to someembodiments. In this regard, the medical device system illustrated ineach of FIGS. 3A and 3B may be configured to detect a conditionindicating a potentially improper energy transmission configuration, forexample, when a transducer or an electrode thereof might be unable toproperly transmit energy. Each of the medical device systems of FIGS. 3Aand 3B includes an electrode-based device system 300, which isillustrated with different views in FIGS. 3C and 3D, according to someembodiments. The electrode-based device system 300 may include severalhundred electrodes 315, but need not include that many. FIG. 3Aillustrates the electrode-based device system 300 in the delivery orunexpanded configuration, according to various example embodiments, andeach of FIGS. 3B, 3C, and 3D illustrates the electrode-based devicesystem 300 in the deployed or expanded configuration, according to someembodiments. FIG. 3E illustrates the electrode-based device system 300with an improper positioning between various members of the structure,according to some embodiments.

In this regard, the electrode-based device system 300 includes aplurality of elongate members 304 (three called out in each of FIGS. 3Aand 3B, 3C, and four called out in each of FIG. 3D and FIG. 3E as 304 a,304 b, 304 c and 304 d) and a plurality of transducers 306 (three calledout in each of FIGS. 3A, 3C and 3D and three called out in FIG. 3B as306 a, 306 b and 306 c). In some embodiments, the transducers 306 havethe configuration of the transducers 220 in FIG. 2. In some embodiments,the transducers 306 are formed as part of or are located on the elongatemembers 304. In some embodiments, the elongate members 304 are arrangedas a frame or structure 308 that is selectively movable between anunexpanded or delivery configuration (e.g., as shown in FIG. 3A) and anexpanded or deployed configuration (e.g., as shown in FIGS. 3B, 3C, and3D) that may be used to position elongate members 304 against a tissuesurface within the bodily cavity or position the elongate members 304 inthe vicinity of, or in contact with, the tissue surface.

In some embodiments, the structure 308 has a size in the unexpanded ordelivery configuration suitable for percutaneous delivery through abodily opening (e.g., via catheter sheath 312, not shown in FIG. 3B) tothe bodily cavity. In some embodiments, structure 308 has a size in theexpanded or deployed configuration too large for percutaneous deliverythrough a bodily opening (e.g., via catheter sheath 312) to the bodilycavity. The elongate members 304 may form part of a flexible circuitstructure (i.e., also known as a flexible printed circuit board (PCB)circuit). The elongate members 304 can include a plurality of differentmaterial layers, and each of the elongate members 304 can include aplurality of different material layers. The structure 308 can include ashape memory material, for instance Nitinol. The structure 308 caninclude a metallic material, for instance stainless steel, ornon-metallic material, for instance polyimide, or both a metallic andnon-metallic material by way of non-limiting example. The incorporationof a specific material into structure 308 may be motivated by variousfactors including the specific requirements of each of the unexpanded ordelivery configuration and expanded or deployed configuration, therequired position or orientation (i.e., pose) or both of structure 308in the bodily cavity, or the requirements for successful ablation of adesired pattern.

The plurality of transducers 306 are positionable within a bodilycavity, for example, by positioning of the structure 308. For instance,in some embodiments, the transducers 306 are able to be positioned in abodily cavity by movement into, within, or into and within the bodilycavity, with or without a change in a configuration of the plurality oftransducers 306 (e.g., a change in a configuration of the structure 308causes a change in configuration of the transducers 306 in someembodiments). In some embodiments, the plurality of transducers 306 arearrangeable to form a two- or three-dimensional distribution, grid orarray capable of mapping, ablating or stimulating an inside surface of abodily cavity or lumen without requiring mechanical scanning. As shownfor example, in FIG. 3A, the plurality of transducers 306 are arrangedin a distribution receivable in a bodily cavity (not shown in FIG. 3A).As shown for example, in FIG. 3A, the plurality of transducers 306 arearranged in a distribution suitable for delivery to a bodily cavity.

FIG. 4 is a schematic side elevation view of at least a portion of anelectrode-based device system 400 that includes a flexible circuitstructure 401 that is employed to provide a plurality of transducers 406(two called out) according to various example embodiments. In someembodiments, the transducers 406 correspond to the transducers 306. Insome embodiments, the flexible circuit structure 401 may form part of astructure (e.g., structure 308) that is selectively movable between adelivery configuration sized for percutaneous delivery and an expandedor deployed configuration sized too large for percutaneous delivery. Insome embodiments, the flexible circuit structure 401 may be located on,or form at least part of, a structural component (e.g., elongate member304) of an electrode-based device system (e.g., electrode-based devicesystem 300).

The flexible circuit structure 401 may be formed by various techniquesincluding flexible printed circuit techniques. In some embodiments, theflexible circuit structure 401 includes various layers includingflexible layers 403 (three called out in FIG. 4 as reference symbols 403a, 403 b and 403 c). In some embodiments, each of the flexible layers403 includes an electrical insulator material (e.g., polyimide). One ormore of the flexible layers 403 may include a different material thananother of the flexible layers 403. In some embodiments, the flexiblecircuit structure 401 includes various electrically conductive layers404 (three called out in FIG. 4 as reference symbols 404 a, 404 b and404 c). The electrically conductive layers 404 may be interleaved withthe flexible layers 403. In some embodiments, each of the electricallyconductive layers 404 is patterned to form various electricallyconductive elements. For example, electrically conductive layer 404 amay be patterned to form a respective electrode 415 included as part ofeach of the transducers 406. Electrodes 415 may have respectiveelectrode edges 415-1 that form a periphery of an electricallyconductive surface or surface portion associated with the respectiveelectrode 415. FIG. 3C shows another example of electrode edges 315-1and illustrates that the electrode edges can defineelectrically-conductive-surface-peripheries of various shapes.

In some embodiments, the respective electrically conductive surface orsurface portion of one or more of the electrodes 415 (or 315) isconfigured to transmit energy to contacting tissue at a level sufficientfor ablation of the tissue. Other energy levels may be transmitted to,for example, provide stimulation (e.g., electrical stimulation that mayinclude pinging or pacing) to tissue within a bodily cavity (e.g., leftatrium 204), sense characteristics of tissue (e.g., electrophysiologicalactivity, convective cooling, permittivity, force, temperature,impedance, thickness, or a combination thereof) within the bodilycavity, or a combination thereof.

Electrically conductive layer 404 b is patterned, in some embodiments,to form respective temperature sensors 408 for each of the transducers406 as well as various leads 410 a arranged to provide electrical energyto the temperature sensors 408. In some embodiments, each temperaturesensor 408 includes a patterned resistive member 409 (two called out)having a predetermined electrical resistance. In some embodiments, eachresistive member 409 includes a metal having relatively high electricalconductivity characteristics (e.g., copper). In some embodiments,electrically conductive layer 404 c is patterned to provide portions ofvarious leads 410 b arranged to provide an electrical communication pathto electrodes 415. In some embodiments, leads 410 b are arranged to passthough vias (not shown) in flexible layers 403 a and 403 b to connectwith electrodes 415. Although FIG. 4 shows flexible layer 403 c as beinga bottom-most layer, some embodiments may include one or more additionallayers underneath flexible layer 403 c, such as one or more structurallayers, such as a stainless steel or composite layer. These one or morestructural layers, in some embodiments, are part of the flexible circuitstructure 401 and can be part of, e.g., elongate member 304. Inaddition, although FIG. 4 shows only three flexible layers 403 a-403 cand only three electrically conductive layers 404 a-404 c, it should benoted that other numbers of flexible layers, other numbers ofelectrically conductive layers, or both, can be included.

In some embodiments, electrodes 415 are employed to selectively deliverRF energy to various tissue structures within a bodily cavity (notshown) (e.g., a tissue cavity such as an intra-cardiac cavity). Theenergy delivered to the tissue structures may be sufficient for ablatingportions of the tissue structures. In various embodiments, the tissuestructures are typically formed from non-fluidic tissue and the energysufficient for ablating portions of the tissue structures is typicallyreferred to as sufficient for tissue ablation. It is noted that energysufficient for non-fluidic-tissue ablation may include energy levelssufficient to disrupt or alter fluidic tissue (e.g., blood) that may,for example, be located proximate the tissue structure. In many cases,the application of non-fluidic-tissue-ablative energy (i.e., energy thatis sufficient to ablate non-fluidic tissue) to fluidic tissue, such asblood, is undesired when the energy is sufficient to disrupt oradversely impact a property of the fluidic tissue. For example, theapplication of non-fluidic-tissue-ablative energy to blood may beundesired when the energy is sufficient to cause various parts of theblood to coagulate in a process typically referred to as thermalcoagulation. In this regard, some embodiments facilitate detection ofconditions where an electrode configured to delivernon-fluidic-tissue-ablative energy may be in a configuration where it isnot able to properly transmit such energy. In some embodiments, adetection of such a condition results in an error notification beingtransmitted or otherwise presented to a user or, in some embodiments, arestriction of that electrode from transmitting at least a portion ofthe non-fluidic-tissue-ablative energy.

The energy delivered to the tissue may be delivered to cause monopolartissue ablation, bipolar tissue ablation, or blended monopolar-bipolartissue ablation by way of non-limiting example. In some embodiments,each electrode 415 is employed to sense an electrical potential in thetissue proximate the electrode 415. In some embodiments, each electrode415 is employed in the generation of an intra-cardiac electrogram. Insome embodiments, each resistive member 409 is positioned adjacent arespective one of the electrodes 415. In some embodiments, each of theresistive members 409 is positioned in a stacked or layered array with arespective one of the electrodes 415 to form a respective one of thetransducers 406. In some embodiments, the resistive members 409 areconnected in series to allow electrical current to pass through all ofthe resistive members 409. In some embodiments, leads 410 a are arrangedto allow for a sampling of electrical voltage between each resistivemembers 409. This arrangement allows for the electrical resistance ofeach resistive member 409 to be accurately determined. The ability toaccurately determine the electrical resistance of each resistive member409 may be motivated by various reasons including determiningtemperature values at locations at least proximate the resistive member409 based at least on changes in the resistance caused by convectivecooling effects (e.g., as provided by blood flow). In variousembodiments, some of the transducers 406 are controlled to provide oneor more electrical signals to tissue (e.g., non-fluidic tissueassociated with a tissue wall or fluidic tissue such as blood) andinformation or a derivative thereof is determined in response to theprovided signals, the information or the derivative thereof indicating aresult of an interaction between the one or more signals and the tissue.In various ones of these embodiments, the one or more signals mayinclude one or more energy levels insufficient for tissue ablation.

In some embodiments in which the electrode-based device system 200 or300 is deployed in a bodily cavity (e.g., when the electrode-baseddevice system 200 or 300 takes the form of a catheter device systemarranged to be percutaneously or intravascularly delivered to a bodilycavity), it may be desirable to perform various mapping procedures inthe bodily cavity. For example, when the bodily cavity is anintra-cardiac cavity, a desired mapping procedure can include mappingelectrophysiological activity in the intra-cardiac cavity. Other desiredmapping procedures can include mapping of various anatomical featureswithin a bodily cavity. An example of the mapping performed by devicesaccording to various embodiments may include locating the position ofthe ports of various bodily openings positioned in fluid communicationwith a bodily cavity. For example, in some embodiments, it may bedesired to determine the locations of various ones of the pulmonaryveins or the mitral valve that each interrupts an interior surface of anintra-cardiac cavity such as a left atrium.

In some example embodiments, the mapping is based at least on locatingbodily openings by differentiating between fluid and non-fluidic tissue(e.g., tissue defining a surface of a bodily cavity). There are manyways to differentiate non-fluidic tissue from a fluid such as blood orto differentiate tissue from a bodily opening in case a fluid is notpresent. Four approaches may include by way of non-limiting example,and, depending upon the particular approach(es) chosen, theconfiguration transducers 406 in FIG. 4 may be implemented accordingly:

1. The use of convective cooling of heated transducer elements by fluid.An arrangement of slightly heated transducer elements that is positionedadjacent to the tissue that forms the interior surface(s) of a bodilycavity and across the ports of the bodily cavity will be cooler at theareas which are spanning the ports carrying the flow of fluid.

2. The use of tissue impedance measurements. A set of transducerspositioned adjacently to tissue that forms the interior surface(s) of abodily cavity and across the ports of the bodily cavity can beresponsive to electrical tissue impedance. Typically, heart tissue willhave higher associated tissue impedance values than the impedance valuesassociated with blood.

3. The use of the differing change in dielectric constant as a functionof frequency between blood and tissue. A set of transducers positionedaround the tissue that forms the interior surface(s) of the atrium andacross the ports of the atrium monitors the ratio of the dielectricconstant from 1 KHz to 100 KHz. Such can be used to determine which ofthose transducers are not proximate to tissue, which is indicative ofthe locations of the ports.

4. The use of transducers that sense force (i.e., force sensors). A setof force detection transducers positioned around the tissue that formsthe interior surface(s) of a bodily cavity and across the bodilyopenings or ports of the bodily cavity can be used to determine which ofthe transducers are not engaged with the tissue, which may be indicativeof the locations of the ports.

Various ones of the above approaches may be used, at least in part, todetermine proximity of a transducer to non-fluidic tissue or to fluidictissue in some embodiments. Various ones of the above approaches may beused, at least in part, to determine contact between a transducer andnon-fluidic tissue or contact between a transducer and fluidic tissue insome embodiments. Various ones of the above approaches may be used, atleast in part, to determine an amount of an electrically conductivesurface portion of an electrode that contacts non-fluidic tissue orcontacts fluidic tissue in some embodiments. Various ones of the aboveapproaches may be used, at least in part, to determine an amount of anelectrically conductive surface portion of an electrode that isavailable for contact with non-fluidic tissue or available for contactwith fluidic tissue in some embodiments, as discussed below.

Referring again to the medical device systems of FIGS. 3A and 3B,according to some embodiments, electrode-based device system 300communicates with, receives power from or is controlled by atransducer-activation system 322, which may include a controller 324 andan energy source device system 340. In some embodiments, the controller324 includes a data processing device system 310 and a memory devicesystem 330 that stores data and instructions that are executable by thedata processing device system 310 to process information received fromother components of the medical device system of FIGS. 3A and 3B or tocontrol operation of components of the medical device system of FIGS. 3Aand 3B, for example by activating various selected transducers 306 toablate tissue, sense tissue characteristics, et cetera. In this regard,the data processing device system 310 may correspond to at least part ofthe data processing device system 110 in FIG. 1, according to someembodiments, and the memory device system 330 may correspond to at leastpart of the memory device system 130 in FIG. 1, according to someembodiments. The energy source device system 340, in some embodiments,is part of an input-output device system 320, which may correspond to atleast part of the input-output device system 120 in FIG. 1. Althoughonly a single controller 324 is illustrated, it should be noted thatsuch controller 324 may be implemented by a plurality of controllers. Insome embodiments, the electrode-based device system 300 (or 200 in FIG.2) is considered to be part of the input-output device system 320. Theinput-output device system 320 may also include a display device system332, a speaker device system 334, or any other device such as thosedescribed above with respect to the input-output device system 120.

In some embodiments, elongate members 304 can form a portion or anextension of control leads 317 that reside, at least in part, in anelongated cable 316 and, at least in part, in a flexible catheter body314. The control leads terminate at a connector 321 or other interfacewith the transducer-activation system 322 and provide communicationpathways between at least the transducers 306 and the controller 324.The control leads 317 may correspond to electrical conductors 216 insome embodiments.

As discussed with respect to FIG. 4, each of various ones of thetransducers 306, 406 includes an electrode 315, 415, according to someembodiments. In these various embodiments, each of at least some of theelectrodes 315, 415 may include a respective energy transmission surface(e.g., energy transmission surface 319 in FIG. 3A) configured totransfer, transmit, or deliver energy, for example, to tissue. In someembodiments, at least some of the respective energy transmissionsurfaces are configured to receive energy, for example, from tissue.Each of the energy transmission surfaces may be bound by a respectiveelectrode edge 315-1 (e.g., FIG. 3C), 415-1 (e.g., FIG. 4).

In various embodiments, each of the electrodes 315 includes anelectrically conductive surface portion (e.g., energy transmissionsurface 319) that, in some embodiments, has an electrical conductivitythat is typically greater than that of fluidic and non-fluidic tissue.In some embodiments, the entirety of the electrically conductive surfaceportion is configured for contact or is configured to be available orexposed for contact with a contiguous portion of a non-fluidic tissuesurface (e.g., a tissue surface that defines a tissue wall). Completecontact between the entirety of the electrically conductive surfaceportion and the non-fluidic tissue may be motivated for differentreasons. For example, various desired characteristics required in alesion formed in a tissue wall in a tissue ablation procedure may bedependent on the degree of intimate contact established between theelectrically conductive surface portion of the electrode 315 and thetissue wall. For example, intimate contact may be required to form alesion having sufficient transmurality to act as an effectiveelectrophysiological activity block (e.g., a block capable of forming abarrier to spurious electrical signals causing fibrillation in anatrium). In some cases, complete contact between the entirety of theelectrically conductive surface portion and the non-fluidic tissue maybe desired to reduce the time required to form a lesion to a desiredtissue depth under the influence of a given ablation energy level. Insome cases, complete contact between the entirety of the electricallyconductive surface portion of the electrode 315 and the non-fluidictissue may be desired to reduce transmission of ablative energy to asurrounding fluidic tissue. In some embodiments, the entirety of theportion of the electrically conductive surface of the electrode 315 thatis configured for contact or is configured to be available or exposedfor contact with a tissue wall surface includes all of the electricallyconductive surface. For example, this may occur when the electricallyconductive surface has a generally planar form (e.g., a generally planarconductive surface provided by an electrode formed by flexible circuitfabrication techniques (e.g., electrode 415)). In some embodiments, theentirety of the portion of the electrically conductive surface of theelectrode that is configured for contact or is configured to beavailable or exposed for contact with a tissue wall surface includessome, but not all, of the electrically conductive surface. For example,this may occur when the electrode has a generally three-dimensionalsurface (e.g., a surface having a cylindrical, hemi-spherical or otherthree-dimensional form) with only a portion less than the entirety ofthe three-dimensional surface configured for contact or configured to beavailable or exposed for contact with a tissue surface wall.

In some embodiments, input-output device system 320 may include asensing device system 325 configured to detect various characteristicsor conditions including, but not limited to, at least one of tissuecharacteristics (e.g., electrical characteristics such as tissueimpedance, tissue type, tissue thickness) and thermal characteristicssuch as temperature. Various other particular conditions described laterin this disclosure may be detected by sensing device system 325according to various embodiments. It is noted that in some embodiments,sensing device system 325 includes various sensing devices ortransducers configured to sense or detect a particular condition whilepositioned within a bodily cavity. In some embodiments, at least part ofthe sensing device system 325 may be provided by electrode-based devicesystem 300 (e.g., various ones of transducers 306). In some embodiments,sensing device system 325 includes various sensing devices ortransducers configured to sense or detect a particular condition whilepositioned outside a given bodily cavity or even outside a body thatincludes the bodily cavity. In some embodiments, the sensing devicesystem 325 may include an ultrasound device system or a fluoroscopydevice system or portions thereof by way of non-limiting example.

The energy source device system 340 may, for example, be connected tovarious selected transducers 306 or their respective electrodes 315 toprovide energy in the form of electrical current or energy (e.g., RFenergy) to the various selected transducers 306 or their respectiveelectrodes 315 to cause ablation of tissue. In this regard, althoughFIGS. 3A and 3B show a communicative connection between the energysource device system 340 and the controller 324 (and its data processingdevice system 310), the energy source device system 340 may also beconnected to the transducers 306 or their respective electrodes 315 viaa communicative connection that is independent of the communicativeconnection with the controller 324 (and its data processing devicesystem 310). For example, the energy source device system 340 mayreceive control signals via the communicative connection with thecontroller 324 (and its data processing device system 310), and, inresponse to such control signals, deliver energy to, receive energyfrom, or both deliver energy to and receive energy from one or more ofthe transducers 306 via a communicative connection with such transducers306 or their respective electrodes 315 (e.g., via one or morecommunication lines through catheter body 314, elongated cable 316 orcatheter sheath) that does not pass through the controller 324. In thisregard, the energy source device system 340 may provide results of itsdelivering energy to, receiving energy from, or both delivering energyto and receiving energy from one or more of the transducers 306 or therespective electrodes 315 to the controller 324 (and its data processingdevice system 310) via the communicative connection between the energysource device system 340 and the controller 324.

The energy source device system 340 may, for example, provide energy inthe form of electrical current to various selected transducers 306 ortheir respective electrodes 315. Determination of a temperaturecharacteristic, an electrical characteristic, or both, at a respectivelocation at least proximate each of the various transducers 306 or theirrespective electrodes 315 may be made under the influence of energy orcurrent provided by the energy source device system 340 in variousembodiments. Energy provided to an electrode 315 by the energy sourcedevice system 340 may in turn be transmittable by the electrodes 315 toadjacent tissue (e.g., tissue forming a tissue wall surface). In variousembodiments, the transmittable energy is sufficient for tissue ablation.In some embodiments, the energy is insufficient for tissue ablation. Theenergy source device system 340 may include various electrical currentsources or electrical power sources. In some embodiments, an indifferentelectrode 326 is provided to receive at least a portion of the energytransmitted by at least some of the transducers 306 or their respectiveelectrodes 315. Consequently, although not shown in FIGS. 3A and 3B, theindifferent electrode may be communicatively connected to the energysource device system 340 via one or more communication lines in someembodiments. The indifferent electrode 326 is typically configured to bepositioned outside of a bodily cavity and may be positioned on anexterior body surface and, in some embodiments, although shownseparately in FIGS. 3A and 3B, is considered part of the energy sourcedevice system 340.

Structure 308 can be delivered and retrieved via a catheter member, forexample, a catheter sheath 312. In some embodiments, the structure 308provides expansion and contraction capabilities for a portion of amedical device (e.g., an arrangement, distribution or array oftransducers 306). The transducers 306 can form part of, be positioned orlocated on, mounted or otherwise carried on the structure 308 and thestructure may be configurable to be appropriately sized to slide withincatheter sheath 312 in order to be deployed percutaneously orintravascularly. FIG. 3A shows one embodiment of such a structure, wherethe elongate members 304, in some embodiments, are stacked in thedelivery or unexpanded configuration to facilitate fitting within theflexible catheter sheath 312. In some embodiments, each of the elongatemembers 304 includes a respective distal end 305 (only one called out inFIG. 3A), a respective proximal end 307 (only one called out in FIG. 3A)and an intermediate portion 309 (only one called out in FIG. 3A, but twoare called out in each of FIGS. 3C and 3D) positioned between theproximal end 307 and the distal end 305. Correspondingly, in someembodiments, structure 308 includes a proximal portion 308 a and adistal portion 308 b. In some embodiments, the proximal and the distalportions 308 a, 308 b include respective portions of elongate members304. The respective intermediate portion 309 of each elongate member 304may include a first or front surface 318 a that is positionable to facean interior tissue surface within a bodily cavity (not shown) and asecond or back surface 318 b opposite across a thickness of theintermediate portion 309 from the front surface 318 a. In someembodiments, each elongate member 304 includes a twisted portion at alocation proximate proximal end 307. Similar twisted portions aredescribed in co-assigned International Application No.:PCT/US2012/022062.

The transducers 306 can be arranged in various distributions orarrangements in various embodiments. In some embodiments, various onesof the transducers 306 are spaced apart from one another in a spacedapart distribution as shown, for example in at least FIGS. 3A and 3B. Insome embodiments, various regions of space are located between variouspairs of the transducers 306. For example, in FIG. 3B theelectrode-based device system 300 includes at least a first transducer306 a, a second transducer 306 b and a third transducer 306 c (allcollectively referred to as transducers 306). In some embodiments eachof the first, the second, and the third transducers 306 a, 306 b and 306c are adjacent transducers in the spaced apart distribution. In someembodiments, the first and the second transducers 306 a, 306 b arelocated on different elongate members 304 while the second and the thirdtransducers 306 b, 306 c are located on a same elongate member 304. Insome embodiments, a first region of space 350 is between the first andthe second transducers 306 a, 306 b. In some embodiments, the firstregion of space 350 is not associated with any physical portion ofstructure 308. In some embodiments, a second region of space 360associated with a physical portion of device system 300 (e.g., a portionof an elongate member 304) is between the second and the thirdtransducers 306 b, 306 c. In some embodiments, each of the first and thesecond regions of space 350, 360 does not include a transducer orelectrode thereof of electrode-based device system 300. In someembodiments, each of the first and the second regions of space 350, 360does not include any transducer or electrode.

It is noted that other embodiments need not employ a group of elongatemembers 304 as employed in the illustrated figures. For example, otherembodiments may employ a structure having one or more surfaces, at leasta portion of the one or more surfaces defining one or more openings inthe structure. In these embodiments, a region of space not associatedwith any physical portion of the structure may extend over at least partof an opening of the one or more openings. In other example embodiments,other structures may be employed to support or carry transducers of atransducer-based device such as a transducer-based catheter. Forexample, an elongated catheter member may be used to distribute thetransducers in a linear or curvilinear array. Basket catheters orballoon catheters may be used to distribute the transducers in atwo-dimensional or three-dimensional array.

In various example embodiments, the energy transmission surface 319 ofeach electrode 315 is provided by an electrically conductive surface. Insome embodiments, each of the electrodes 315 is located on varioussurfaces of an elongate member 304 (e.g., front surfaces 318 a or backsurfaces 318 b). In some embodiments, various electrodes 315 are locatedon one, but not both of the respective front surface 318 a andrespective back surface 318 b of each of various ones of the elongatemembers 304. For example, various electrodes 315 may be located only onthe respective front surfaces 318 a of each of the various ones of theelongate members 304. Three of the electrodes 315 are identified aselectrodes 315 a, 315 b and 315 c in FIG. 3B. Three of the energytransmission surfaces 319 are identified as 319 a, 319 b and 319 c inFIG. 3B.

FIG. 3C is a perspective view of the expandable structure 308 of themedical device system of FIG. 3A in the expanded or deployedconfiguration, as viewed from a different viewing angle than thatemployed in FIG. 3B, according to some embodiments. For clarity ofillustration, only structure 308 including various ones of the elongatemembers 304, and a portion of catheter body 314 are shown in FIG. 3C. Insome embodiments, the respective intermediate portions 309 (only twocalled out) of various ones of the elongate members 304 are angularlyarranged with respect to one another about a first axis 335 a whenstructure 308 is in the deployed configuration.

FIG. 3D is a plan view of structure 308 in the deployed or expandedconfiguration of FIG. 3C. The plan view of FIG. 3D has an orientationsuch that the first axis 335 a is viewed along the axis in thisparticular embodiment. First axis 335 a is represented by an “x” symbolin FIG. 3D as entering and coming out of the page. It is understood thatthe depicted symbol “x” used to represent first axis 335 a does notimpart any size or shape attributes to the first axis 335 a.

In various embodiments, at least some of the transducers 306 areradially spaced about first axis 335 a when structure 308 is in thedeployed configuration. For example, various ones of the electrodes 315are radially spaced about first axis 335 a in the deployed configurationin at least some of the embodiments associated with various ones ofFIGS. 3B, 3C, 3D and 3E. In various embodiments, at least some of thetransducers 306 are circumferentially arranged about first axis 335 awhen structure 308 is in the deployed configuration. For example,various ones of the electrodes 315 are circumferentially arranged aboutfirst axis 335 a in the deployed configuration in at least some of theembodiments associated with various ones of FIGS. 3B, 3C, 3D and 3E. Itis understood that although electrodes are referred to in thesedescribed embodiments, the same analysis applies to the correspondingtransducers in some embodiments.

It may be noted that distances between adjacent ones of the elongatemembers 304 shown in FIGS. 3B 3C, 3D and 3E vary as elongate members 304extend towards first axis 335 a when structure 308 is in the deployedconfiguration. In some cases, the varying distances between adjacentelongate members 304 in the deployed configuration may give rise toshape, size or dimensional constraints for the electrodes 315 located onthe elongate members 304. In some cases, the overlapping portions ofvarious ones the elongate members 304 in the deployed configuration maygive rise to shape, size or dimensional constraints for the electrodes315 located on the portions of the various ones of the elongate members304. For example, it may be desirable to reduce a surface area of anelectrode adjacent an overlap region on an overlapped elongate member toaccommodate the reduced-exposed-surface area of the overlapped elongatemember in the region adjacent the overlap region (e.g., electrode 315 din FIG. 3D).

In various embodiments, the respective shape of various electricallyconductive surfaces (e.g., energy transmission surfaces 319) of variousones of the electrodes 315 vary among the electrodes 315. In variousembodiments, the respective shape of various electrically conductivesurfaces (e.g., energy transmission surfaces 319) of various ones of theelectrodes 315 vary among the electrodes 315 in accordance with theirproximity to first axis 335 a. In various embodiments, one or moredimensions or sizes of various electrically conductive surfaces (e.g.,energy transmission surfaces 319) of at least some of the electrodes 315vary among the electrodes 315. In various embodiments, one or moredimensional sizes of various electrically conductive surfaces (e.g.,energy transmission surfaces 319) of at least some of the electrodes 315vary in accordance with their proximity to first axis 335 a. The shapeor size variances associated with various ones of the electrodes 315 maybe motivated for various reasons. For example, in various embodiments,the shapes or sizes of various ones of the electrodes 315 may becontrolled in response to various ones of the aforementioned size ordimensional constraints.

FIG. 5 is a block diagram of a method 500 employed according to someexample embodiments, while FIGS. 5A-5G represent exploded views of someof the blocks shown in FIG. 5, according to various embodiments. One ormore of the methods of FIGS. 5 and 5A-5G may be executed or implementedat least by one or more of the components of the system 100 of FIG. 1 orthe systems of FIGS. 3A and 3B. For example, in some embodiments, amemory device system (e.g., memory device systems 130 or 330) iscommunicatively connected to a data processing device system (e.g., dataprocessing device systems 110 or 310) and stores a program executable bythe data processing device system to cause the data processing devicesystem to execute one or more of the methods of FIGS. 5 and 5A-5G viainteraction with at least, for example, an electrode-based device system(e.g., electrode-based device system 200 or 300) or sensing devicesystem (e.g., 325) or data provided by such an electrode-based devicesystem or sensing device system. In these various embodiments, theprogram may include instructions configured to perform, or cause to beperformed, the tasks or processes associated with one or more of theblocks in one or more of the methods illustrated in FIGS. 5 and 5A-5G.In some embodiments, method 500 including its exploded examples in FIGS.5A-5G may include a subset of the associated blocks or additional blocksas compared to those shown in the respective figures. In someembodiments, method 500 including its exploded examples in FIGS. 5A-5Gmay include a different sequence between various ones of the associatedblocks as compared to that shown in the respective figures.

In regard to FIG. 5, block 504 is associated with acquisitioninstructions configured to acquire information stored in the memorydevice system, according to some embodiments. The information stored inthe memory device system may be provided to the memory device system invarious ways. For example, in some embodiments, an input-output devicesystem (e.g., 120 or 320) may be communicatively connected to the memorydevice system (possibly by way of the data processing device system)and, consequently, may provide the information that is stored in thememory device system according to storage instructions associated withblock 503. In this regard, the input-output device system may include anelectrode-based device system (e.g., 200 or 300) that provides theinformation, which may be received by the data processing device systemaccording to reception instructions associated with block 502A andstored in the memory device system according to the storage instructionsassociated with block 503. In some embodiments, the input-output devicesystem includes a sensing device system (e.g., 325) that provides theinformation, which may be received by the data processing device systemaccording to reception instructions associated with block 502B andstored in the memory device system according to the storage instructionsassociated with block 503. However, the input-output device system neednot include an electrode-based device system or a sensing device system,and, in this regard, the information stored according to theinstructions associated with block 503 may be information thatoriginated at an electrode-based device system or a sensing devicesystem, but reached the memory device system indirectly from some othersource. For example, an electrode-based device system (e.g., 200 or 300)may be in wireless communication with a transceiver that is part of theinput-output device system (e.g., 120), and this transceiver providesinformation from the electrode-based device system for storage in thememory device system according to the instructions associated with block503. For another example, a user monitoring the electrode-based devicesystem may merely manually input information from the electrode-baseddevice system into an interface terminal of the input-output devicesystem (e.g., 120), which is then received by the data processing devicesystem (e.g., 110) and stored in the memory device system (e.g., 130)according to the instructions associated with block 503.

In embodiments where block 502A is used, the electrode-based devicesystem may be configured to provide to the data processing device systeminformation in the form of one or more electrical signals from itstransducers (e.g., transducers 206, 306 or 406) while positioned in thebodily cavity. In some embodiments, the one or more electrical signalsare provided to tissue (e.g., non-fluidic tissue making up a tissue wallor fluidic tissue such a blood). In some embodiments, the informationstored according to the instructions associated with block 503 indicatesa result of an interaction between the one or more electrical signalsand the tissue. The one or more electrical signals may include levelsinsufficient for tissue ablation. In some embodiments, the interactionbetween the one or more electrical signals and the tissue may be anelectrical interaction. For example, the information stored in thememory device system according to the storage instructions associatedwith block 503 may include electrical impedance information determinedfrom the interaction.

In embodiments where block 502B is used, it should be noted that thesensing device system (e.g., 325) may include a portion of anelectrode-based device system (e.g., electrode-based device system 200or 300) that is positionable in a particular bodily cavity. In someembodiments, the sensing device system 325 may include varioustransducers (e.g., emitters, detectors, et cetera) positionable outsidethe bodily cavity or even outside the body. In some embodiments, thesensing device system 325 may include an ultrasound device system or afluoroscopy device system or portions thereof by way of non-limitingexample.

Accordingly, the information acquired according to the instructionsassociated with block 504 may be any information that facilitatesdetection of a condition detected according to the instructionsassociated with block 506, discussed below. For example, the informationacquired according to block 504 may include impedance information,positional information, fluid flow information, convective heatinformation, temperature information, or a combination of these items,and such information may be provided by the electrode-based devicesystem (e.g., block 502A), the sensing device system (e.g., block 502B),or both.

In this regard, block 506 of method 500 is associated with detectioninstructions configured to detect a particular condition or conditionsbased on an analysis of the information acquired according to theacquisition instructions associated with block 504. The particularcondition or conditions may be indicative of an improper energytransmission or delivery configuration where energy intended to betransmitted or delivered to one location could instead be delivered toanother location and, in some medical device embodiments, might lead toan undesired result. Various conditions that may be caused to bedetected under the influence of the detection instructions associatedwith block 506 are described later in this disclosure.

In some embodiments, Block 508 of method 500 is associated with storageinstructions configured to cause a storage in the memory device system(e.g., 130 in FIG. 1) of detection information indicating a detection ofthe particular condition or conditions detected according to thedetection instructions associated with block 504.

Upon a detection or determination of the particular condition(s)according to the instructions associated with block 506, a result ofsuch detection or determination may be stored in the memory devicesystem (e.g., 130 in FIG. 1) according to the instructions associatedwith block 508 in FIG. 5. Such detection or determination may also leadto the presenting of an error notification according to the instructionsassociated with block 512 or a restriction of energy transmittable byone or more electrodes according to the instructions associated withblock 510 in FIG. 5, according to some embodiments.

In this regard, the method 500 may include restriction instructions(e.g., associated with block 510 in FIG. 5) configured to control thedata processing device system to cause a restriction of energytransmittable by at least a first electrode in response to theparticular condition(s) detected according to the detection instructionsassociated with block 506. In some embodiments, the energy transmittableby the first electrode is restricted to one or more levels insufficientfor tissue ablation. In some embodiments, the energy transmittable bythe first electrode is restricted to levels insufficient for detectionat various locations at least proximate the first electrode. In someembodiments, the data processing device system causes, under theinfluence of the restriction instructions, a restriction or preventionof a flow of energy between an energy source device system (e.g., energysource device system 340) and the first electrode. In this regard,detection of a condition that may be indicative of an improper energytransmission or delivery configuration where energy intended to betransmitted or delivered to one location could instead be delivered toanother location may result in prevention of energy delivery or at leastrestriction of energy delivery to a level configured to prevent anundesired outcome.

In some embodiments, method 500 includes failure state instructions(e.g., associated with block 512 in FIG. 5) configured to cause theinput-output device system to present an error notification to a user inresponse to the particular condition(s) being detected according to thedetection instructions associated with block 506. The error notificationmay be provided visually to the user via a display device system (e.g.,display device system 332) or audibly via a speaker device system (e.g.,speaker device system 334) by way of non-limiting example. In thisregard, detection of a condition that may be indicative of an improperenergy transmission or delivery configuration where energy intended tobe transmitted or delivered to one location could instead be deliveredto another location may result in a user being notified at least of thepotential for improper operation.

Turning now to FIG. 5A, an exploded view, according to some embodiments,of steps 504 and 506 of FIG. 5 is illustrated. In this regard, FIG. 5Aillustrates with block 504A that, in some embodiments, the informationacquired according to the acquisition instructions associated with block504 includes positional information indicative of a deviation from anexpected positioning of the electrode-based device system (e.g., 200 or300). In some embodiments, the instructions associated with block 506can include, as illustrated with block 506A, instructions configured tocause detection of such a deviation from expected positioning of theelectrode-based device system, based on an analysis of the positionalinformation acquired according to block 504A. It should be noted thatalthough block 504A is illustrated in the context of FIG. 5A as exampleembodiments of FIG. 5, block 504A could be applied to any of theembodiments of FIGS. 5B-5G as well.

In some embodiments, the expected positioning of the electrode-baseddevice system is an intended, designed, or proper operational state ofthe electrode-based device system. Of course, a device system, such asthe electrode-based device system, may have many intended, designed, orproper operational states, and, in this regard, the expected positioningmay be a subset of these states and may depend upon the device system'senvironment and one or more particular or selected functions of thedevice system.

For example, in some embodiments, FIG. 3D illustrates one intended,designed, or proper operational state of the electrode-based devicesystem 300 that might exist when such system 300 is not subject toexternal forces, such as that from a tissue wall pressing against someelongate members 304. Of course, the system 300 also is intended ordesigned to properly operate in conditions where the system 300 isdeformed due to, e.g., a tissue wall pressing against at least someelongate members in some embodiments. Accordingly, in some embodiments,when it is known that the system 300 is deployed in a left atrium of ahuman heart that is somewhat smaller than the system 300 in a deployedconfiguration, it might be expected that the system 300 will experiencesome deformation, but not to a point where various ones of theelectrodes 315 are contacting a physical portion of the electrode-baseddevice system 300 (instead of being available for contact with tissue).In these cases, an expected positioning of the electrode-based devicesystem might be that none of the various ones of the electrodes arecontacting a physical portion of the electrode-based device system 300,according to some embodiments. In some embodiments, situations may arisein which various ones of the electrodes 315 are not contacting aphysical portion of the electrode-based device system 300, but, rather,are improperly positioned too close to the physical portion of theelectrode-based device system 300 in a manner that could negativelyimpact energy delivery characteristics of the various ones of theelectrodes 315. In these cases, a desired or an expected positioning ofthe electrode-based device system might be that none of the various onesof the electrodes are too close to a physical portion of theelectrode-based device system 300, according to some embodiments.

Similarly, the expected positioning of the electrode-based device systemmight be based on a particular function or functions of the devicesystem. For example, in some embodiments, if an ablative-energy-deliveryfunction of the electrode-based device system is deemed of interest(e.g., by an operator), the expected positioning of the electrode-baseddevice system may be defined in terms of this function, for example, bydefining the expected positioning to be a configuration that allows theelectrodes to properly deliver or transmit their respective ablativeenergies. Accordingly, the definition of expected positioning of atleast a portion of the electrode-based device system may be selected tofit particular circumstances.

Deviations from expected positioning need not only arise due todeformation of the electrode-based device system 300, but can also arisefor other reasons. For example, an improper positioning of a portion ofthe electrode-based device system 300 may occur when the structure 308is moved between a delivery configuration and a deployed configuration.In this regard, FIG. 3E provides an example of a deviation in anexpected positioning between a first electrode 315-1 a and a physicalportion (e.g., an elongate member 304) of the electrode-based devicesystem 300 when the structure 308 on which the first electrode 315-1 ais located is positioned in the deployed configuration. It is understoodthat reference to electrode 315-1 a as the first electrode in variousembodiments herein described in this disclosure is made for convenienceof discussion and any electrode described as a first electrode in thevarious embodiments may include electrodes other than electrode 315-1 a(e.g., any of electrodes 315, 415 by way of non-limiting example). InFIG. 3E, first electrode 315-1 a is located on an elongate member 304 c.As compared with an expected positioning between the first electrode315-1 a and elongate member 304 d shown in FIG. 3D, a deviation in theexpected positioning between first electrode 315-1 a and the elongatemember 304 d is shown in FIG. 3E. In this case, the deviation in theexpected positioning between first electrode 315-1 a and the elongatemember 304 d occurs when structure 308 is in the deployed configuration.In FIG. 3E, elongate member 304 d is positioned such that it overlaps atleast a portion of the first electrode 315-1 a. Varying degrees oramounts of overlap may occur. In FIG. 3E, elongate member 304 d ispositioned such that it overlaps some, but not all, of an electricallyconductive surface portion (e.g., energy transmission surface 319-1 a)associated with first electrode 315-1 a. The deviation in the expectedpositioning between the first electrode 315-1 a and the elongate member304 d may arise from an improper positioning of (a) the first electrode315-1 a (e.g., via an improper positioning of elongate member 304 c),(b) an improper positioning of elongate member 304 d, or both (a) and(b). In this particular case, the deviation in the expected positioningbetween the first electrode 315-1 a and the elongate member 304 d hasoccurred because of an improper positioning of elongate member 304 d,which may be caused due to the elongate member 304 d improperlydeploying from the delivery configuration.

Other causes of a deviation from an expected positioning, such as thatillustrated in FIG. 3E, of at least a portion of an electrode-baseddevice system (e.g., 300) include interaction or interference with ananatomical structure as the structure 308 is moved between a deliveryconfiguration and a deployed configuration. In some cases, positioningthe structure 308 adjacent to, or in contact with tissue may cause animproper positioning of a portion of the electrode-based device system300. For example, contact with a highly irregular tissue surface maylead to varying degrees of misposition. In some cases, when part of anelectrode-based device system is improperly sized for a desireddeployment in a bodily cavity, an improper positioning of the portion ofthe electrode-based device system may result when the part of theelectrode-based device system is deployed in the bodily cavity. In somecases, interaction or interference with ancillary or other devicesystems used in conjunction with the electrode-based device system maycause an improper positioning of the portion of the electrode-baseddevice system. Ancillary or other device systems may include a secondelectrode (e.g., a roving electrode). Roving electrodes employed byancillary or other device systems may be used to determine a location,orientation or pose of at least part of an electrode-based-base devicesystem in some example embodiments. By way of non-limiting example,ancillary or other device systems may respectively include othertreatment or diagnostic device systems that may be used in conjunctionwith an electrode-based device system. In some cases, a deployment erroror malfunction during one or more actuations of an electrode-baseddevice system may cause an improper positioning of the portion of theelectrode-based device system.

Any information that facilitates detection of or is indicative of theabove-discussed deviation (e.g., FIG. 3E or any other deviation orparticular condition (e.g., block 506)) from an expected positioning ofat least a portion of an electrode-based device system according to theinstructions associated with block 506A may be acquired according to theinstructions associated with block 504A in FIG. 5A. Such information mayinclude information that facilitates detection of or is indicative ofthe present positioning of at least a portion of the electrode-baseddevice system and that is provided by the electrode-based device systemitself (e.g., 200 or 300) or by another sensing device system (e.g.,325) that is working along with the electrode-based device system (e.g.,internally (in the bodily cavity), such as by a roving electrode, orexternally by fluoroscopy or ultrasound). Having an understanding of thepresent positioning of the electrode-based device system via informationacquired according to block 504 in FIG. 5 or 504A in FIG. 5A allows acomparison of the present positioning with the expected positioning,which may be predetermined and pre-stored in the memory device system130, and such a comparison may lead to a detection of the particularcondition (e.g., block 506 in FIG. 5), which may be a deviation from theexpected positioning (e.g., block 506A in FIG. 5A). It should be noted,however, that the expected positioning need not be pre-determined orpre-stored in a memory device system, and the particular condition maybe detected without a comparison to a pre-determined/pre-stored expectedpositioning. For example, detecting an error condition in informationacquired according to the instructions associated with block 504 or 504Amay result in the detection of the particular condition(s) as block 506or 506A without need for comparison to an expected positioning. Forinstance, as discussed below, detection of a shunt condition ordetection of a proximity below a threshold amount between an electrodeand an object other than tissue may lead to a detection of an improperenergy transmission configuration or a deviation in an expectedpositioning of at least one portion of the electrode-based devicesystem.

In some embodiments, information acquired according to block 504 thatfacilitates detection of or is indicative of the particular condition(s)of block 506, or in the case of block 506A, the deviation from anexpected positioning of at least a portion of the electrode-based devicesystem, may include impedance information (e.g., associated with atleast one electrode, such as the first electrode 315-1 a), positionalinformation, fluid flow information, convective heat information,temperature information, or a combination of these items. In theembodiments associated with FIG. 5A, the information acquired accordingto the instructions associated with block 504A includes positionalinformation. This positional information, however, need not (but may, insome embodiments) take the form of positional mapping information thatmay, for example, employ various indicators such as locationalcoordinate systems and the like. Alternatively, the positionalinformation may include impedance information, fluid flow information,convective heat information, temperature information, a combination ofthese items, or any other information that may facilitate identificationof a present positioning of the electrode-based device system.

In this regard, the positional information can indicate variousconditions. As with the example of FIG. 3E, the positional informationmay be indicative of a deviation in an expected positioning between afirst electrode 315-1 a and a physical portion of the electrode-baseddevice system 300 when the structure 308 on which the first electrode315-1 a is located is positioned in the deployed configuration.Similarly, positional information that indicates the condition of FIG.3E also may indicate that a portion of the structure 308 is not in anexpected position with respect to tissue adjacent the portion of thestructure. For example, the condition of FIG. 3E may indicate that theportion of the first electrode 315-1 a (an example of a portion of thestructure 308) that is overlapped is not in its expected position wherea desired portion of a tissue contact surface of the first electrode315-1 a should be in contact with or at least be available or fullyexposed for contact with tissue of a tissue wall that is adjacent thefirst electrode 315-1 a. Positional information, such as an impedancereading from the first electrode 315-1 a, that indicates that theelectrode 315-1 a is not fully available for contact or fully in contactwith tissue indicates the condition of FIG. 3E which may, consequently,be detected according to the instructions associated with block 506based on an analysis of such impedance reading.

In some embodiments, where a structure includes a plurality of elongatemembers (e.g., structure 308 including elongate members 304) with atleast some of a plurality of electrodes located on each of the pluralityof elongate members, the first electrode may be located on a firstelongate member of the plurality of elongate members and the informationacquired according to the acquisition instructions associated with block504A may include positional information indicative of a deviation in anexpected positioning between the first electrode and at least a secondelongate member of the plurality of elongate members (e.g., an elongatemember other than the first elongate member) when the structure ispositioned in the bodily cavity in the deployed configuration. In someembodiments, the structure may include one or more elongate members withat least some of a plurality of electrodes located on each of the one ormore elongate members (for example, a single elongate member on which agroup of electrodes is located, the single elongate member having acurvilinear form in the deployed configuration). In various embodiments,the first electrode may be an electrode located on a first elongatemember of the one or more elongate members and the information acquiredaccording to the acquisition instructions associated with block 504 mayinclude positional information indicative of a deviation in an expectedpositioning between the first electrode and an elongate member of theone or more elongate members when the structure is positioned in thebodily cavity in the deployed configuration. In various embodiments, thefirst electrode may be an electrode located on a first elongate memberof the one or more elongate members and the information acquiredaccording to the acquisition instructions associated with block 504 mayinclude positional information indicative of a deviation in an expectedpositioning between the first electrode and a second electrode of theplurality of electrodes (i.e., other than the first electrode) when thestructure is positioned in the bodily cavity in the deployedconfiguration. In some of these various embodiments, the secondelectrode may be located on the first elongate member. In some of thesevarious embodiments, the one or more elongate members include aplurality of elongate members, and the second electrode is located onone of the plurality of elongate members other than the first elongatemember. Different forms of positional deviations may be indicated inother embodiments. In some embodiments, the information acquiredaccording to the acquisition instructions associated with block 504includes positional information indicative of a deviation in an expectedpositioning between a portion of the electrode-based device system(e.g., electrode, structural member) and a tissue structure within abodily cavity in which the portion of the electrode-based device systemis positioned.

FIG. 5B includes exploded views of the block 506 as employed in variousembodiments. In this regard, block 506 may include a block 506B whoseassociated instructions are configured to cause a detection of aparticular condition based on an analysis of the information acquiredaccording to the acquisition instructions associated with block 504 (orblock 504A, e.g.), the particular condition indicating that some, butnot all, of the respective electrically conductive surface portion of atleast the first electrode (e.g., first electrode 315-1 a) is availablefor contact with tissue of a tissue wall of a bodily cavity (e.g., leftatrium 204). This particular condition may be detected in similarmanners described above with respect to FIGS. 5A and 3E, where theoverlapped first electrode 315-1 a in FIG. 3E may be considered to havesome, but not all, of its electrically conductive surface portion(defined, in some embodiments, by an electrode edge 415-1 in FIG. 4)available for contact with tissue due to the overlapping. In some ofthese various embodiments, this particular condition is detected when astructure (e.g., 308) on which the first electrode (e.g., firstelectrode 315-1 a) is located is positioned in the bodily cavity in thedeployed configuration. In some of these various embodiments, theentirety of the electrically conductive surface portion of each of atleast the first electrode is configured, in absence of the particularcondition, for contact with a contiguous surface portion of the tissuewall when the structure on which the first electrode is located ispositioned in the bodily cavity in the deployed configuration. Forexample, the entirety of the electrically conductive surface portion ofthe first electrode (e.g., 315-1 a) is configured to be available forcontact, as shown in FIG. 3D, when the condition of FIG. 3E is absent.In some embodiments, at least part of the electrically conductivesurface portion (e.g., at least part of the energy transmission surface)of the first electrode (e.g., 315-1 a) is positioned to face towards asurface portion of the tissue wall when the structure (e.g., 308) ispositioned in the bodily cavity in the deployed configuration. In someof these embodiments, the condition is associated with a positioning ofa physical portion (e.g., elongate member 304 d, which is a portion ofthe structure 308; the first electrode being located on the structure308) of the electrode-based device system between the electricallyconductive surface portion of the first electrode and the surfaceportion of the tissue wall when the structure is positioned in thebodily cavity in the deployed configuration. In other words, in someembodiments, the condition detected according to the instructionsassociated with block 506B may be associated with a physical portion(e.g., elongate member 304 d) of the electrode-based device system beingbetween the first electrode (e.g., 315-1 a) and the tissue wall.

In some particular embodiments associated with FIG. 3E, structure 308includes a plurality of elongate members 304 with at least some of theplurality of electrodes 315 located on each of the plurality of elongatemembers 304. In the some of these particular embodiments, at least someof the electrodes 315 are located on one, but not both, of therespective front and back surfaces 318 a, 318 b (only front surfaces 318a called out in FIG. 3E) of each of the plurality of elongate members304. In FIG. 3E, at least the first electrode 315-1 a is located on therespective front surface 318 a of a first elongate member (i.e.,elongate member 304 c) and the information acquired according to theacquisition instructions of block 504 may include positional informationindicative of a positioning when at least part of the electricallyconductive surface portion of the first electrode 315-1 a faces therespective back surface 318 b (not called out) of the second elongatemember (e.g., elongate member 304 d) when structure 308 is positioned inthe bodily cavity in the deployed configuration. In various ones ofembodiments described above, the detected conditions may arise becauseof a deviation in an expected positioning between the first electrodeand some physical portion of the electrode-based device system.

It should be noted that a deviation detected in accordance with thedetection instructions associated with 506A may also be related to theparticular condition detected in accordance with the detectioninstructions associated with 506B or any other instructions associatedwith block 506 as well as various other instruction blocks that may beassociated with method 500. For example, a deviation detected inaccordance with block 506A may also be indicative of the particularcondition detected in accordance with block 506B and vice-versa.

In some embodiments, the detection of a particular condition inaccordance with a particular constituent detection instruction setassociated with 506 may cause storage instructions associated with block508 to additionally or alternatively store information that is relatedto another particular condition that is detectable by another particulardetection instruction set associated with block 506. It is noted that insome embodiments, activity initiated by (a) the restriction instructionsassociated with 510, (b) the failure state instructions associated with512 or both (a) and (b) may be dependent on (c) the detectioninformation indicating the result of the detection of a particularcondition according to the detection instructions of any of theconstituent detection instruction sets associated with block 506 orvarious other blocks of method 500, (d) determination informationindicating a particular determination indicating a result ofdetermination instructions associated with various blocks of method 500,or (e) various information stored in the memory device system by thestorage instructions associated with 508.

FIG. 5C includes an exploded view of block 506 as employed in variousembodiments. In this regard, block 506 may include a block 506C whoseassociated instructions are configured to cause a detection of aparticular condition based on an analysis of the information acquiredaccording to the acquisition instructions associated with block 504, theparticular condition indicating contact (e.g., a contact condition)between a non-tissue based surface positioned in the bodily cavity andthe electrically conductive surface portion of the first electrode(e.g., first electrode 315-1 a) when a structure on which the firstelectrode is located (e.g., structure 308) is positioned in the bodilycavity in the deployed configuration. The non-tissue based surface maytake various forms in various ones of these embodiments. For example,the non-tissue based surface may be a surface of a second electrodeother than the first electrode. In some embodiments, the secondelectrode is a roving electrode that is not located on the structure. Insome embodiments, the second electrode is an electrode that is alsolocated on the structure. In some embodiments, the non-tissue basedsurface does not form part of any electrode (e.g., a portion of anelongate member 304 that does not include an electrode). In someembodiments, the non-tissue based surface forms a surface of a physicalportion of the electrode-based device system that includes the firstelectrode (e.g., elongate member 304). In some embodiments, thenon-tissue based surface forms a portion of the structure. For examplein FIG. 3E, the non-tissue based surface may form part of the backsurface 318 b (not called out) of the second elongate member 304 d.

Contact between a first electrode (e.g., first electrode 315-1 a) and anon-tissue based surface can be detected in various ways, such as thosedescribed above with respect to FIG. 5A and FIG. 3E. Other techniquesmay be used (e.g., various imaging techniques) however, not only for theembodiments of FIG. 5C, but also for the embodiments of FIGS. 5A, 5B,5D, 5E, 5F, and 5G. For example, in some embodiments, when thenon-tissue based surface is an electrically conductive non-tissue basedsurface, contact between the first electrode and the electricallyconductive non-tissue based surface may be detected by detecting a shuntcondition (also referred to as shunted condition).

FIG. 5D includes an exploded view of the block 506 as employed invarious embodiments. In this regard, block 506 may include a block 506Dwhose associated instructions are configured to cause a detection of aparticular condition based on an analysis of the information acquiredaccording to the acquisition instructions associated with block 504, theparticular condition being a shunt condition, the shunt conditionassociated with a diversion of a portion of energy transmittable by afirst electrode (e.g., first electrode 315-1 a located on structure 308)positionable in a bodily cavity (e.g., left atrium 204) defined at leastin part by a tissue wall. In various embodiments, the shunt condition iscreated in an electric circuit that includes at least the firstelectrode. In some embodiments, the shunt condition includes a diversionof a portion, but not all, of energy transmittable by the firstelectrode away from adjacent tissue of the tissue wall, the adjacenttissue adjacent the first electrode. In some embodiments, the energytransmittable by the first electrode is sufficient for tissue ablation.However, in some embodiments, the energy transmittable by the firstelectrode is insufficient for tissue ablation.

In some embodiments, as shown with block 514 in FIG. 5E the detection ofthe shunt condition may lead to a determination of a deviation in anexpected positioning, as discussed above with respect to block 506A inFIG. 5A. In the example of block 514, the deviation in expected positionmay be between a first electrode and a physical portion of anelectrode-based device system, at least when a structure (e.g., 308) ofthe electrode-based device system on which the first electrode islocated, is in a deployed configuration. In this regard, a detectedshunt condition may indicate and lead to a determination of an improperenergy delivery configuration such as that shown in FIG. 3E.

In some embodiments, the shunt condition includes a diversion of theportion of the energy transmittable by the first electrode fromtraveling along (a) a first electrical path extending from the firstelectrode to the adjacent tissue of the tissue wall, to (b) a secondelectrical path extending from the first electrode away from theadjacent tissue of the tissue wall. For example, FIG. 6A is a schematiccross-sectional view of a first electrode 615-1 a positioned adjacenttissue 621 a of a tissue wall 622 a that defines at least part of abodily cavity 624 a, the adjacent tissue 621 a located adjacent firstelectrode 615-1 a. First electrode 615-1 a is located on a portion of astructural member 604-1 a (e.g., an elongate member 304). In FIG. 6A,energy is transmittable from the first electrode 615-1 a to a secondelectrode 626 a along a first electrical path (schematically depicted atleast in part by electric field lines 625 a) extending from the firstelectrode 615-1 a to the second electrode 626 a. In various embodiments,the second electrode is an indifferent electrode configured to bepositioned outside of the bodily cavity 624 a or even outside a bodythat includes the bodily cavity 624 a. It is understood that that eachof the various tissue walls depicted in FIG. 6 (e.g., tissue wall 622 a,622 b, or 622 c) need not include a single tissue layer, but may alsoinclude multiple combinations of non-fluidic tissue and fluidic tissueor multiple layers of different tissue. The first electrical path may beassociated with monopolar ablation in various example embodiments. It isnoted that in this disclosure, the use of field lines such as fieldlines 625 a to schematically illustrate an electrical path is employedmerely for the convenience of discussion and it is understood thatelectrical paths described in various embodiments can take variousdifferent forms or can be illustrated in other manners. As used herein,the phrase “electrical path” is typically associated with a flow ofelectrical current, the electrical current preferentially following aparticular route along which the path electrical impedance is thelowest. Some electrical paths may be readily identified (e.g.,electrical current flowing through a conductor having a relatively highelectrical conductivity such as a metallic conductor). Other electricalpaths may be more difficult to identify (e.g., electrical currentflowing through tissue made up of different constituent tissue parts).In this disclosure, the diversion of energy or electrical currentflowing along a first electrical path to a different second electricalpath is typically characterized by a lower path impedance being presentalong the second electrical path.

FIG. 6B is a top view of FIG. 6A from within the bodily cavity 624 afrom above the structural member 604-1 a and looking towards thestructural member 604-1 a. In this regard, the first electrode 615-1 ais shown in broken lines, and structural member 604-1 a is shown overthe tissue wall 622 a. Some of the electric field lines 625 a arerepresented by the symbols “●” in FIG. 6B. The electric field lines havea relatively high electric field density in this embodiment. Arelatively high electric field density may be required for effectivetissue ablation in various embodiments.

FIG. 6C includes a shunt condition associated with various exampleembodiments where a diversion occurs of a portion of energytransmittable by the first electrode 615-1 a from the first electricalpath (e.g., FIGS. 6A, 6B) to a second electrical path schematicallydepicted at least in part by electric field lines 625 b different thanthe first electrical path. In some of these example embodiments, theshunt condition is configured to occur at least when contact between thefirst electrode 615-1 a (or an electrically conductive surface portionthereof) and a first non-tissue based electrically conductive surface630-1 (in the example of FIG. 6C, a rear surface of an overlappingstructural member 604-1 b on which another electrode 615-1 b is located,the rear surface facing inwardly into bodily cavity 624 a) located inthe bodily cavity 624 a is established. In some of these exampleembodiments, the shunt condition includes a diversion of a portion ofthe energy transmittable by the first electrode 615-1 a to the firstnon-tissue based electrically conductive surface 630-1.

It should be noted that a non-tissue based electrically conductivesurface (such as surface 630-1 or any other non-tissue basedelectrically conductive surface discussed in this disclosure) can formpart of any number of different devices according to variousembodiments. For example, a non-tissue based electrically conductivesurface may be a surface of an electrode (e.g., a roving electrode) thatis not located on the structure (e.g., 308) on which the first electrode(e.g., first electrode 615-1 a) is located. In some embodiments, anon-tissue based electrically conductive surface may be a surface ofanother electrode besides the first electrode located on a structure onwhich the first electrode is located. However, in some embodiments, anon-tissue based electrically conductive surface does not form part ofany electrode. For example, a first non-tissue based electricallyconductive surface may form an electrically conductive surface orportion (e.g., a metallic surface or portion) of a device or structure(e.g., 308) of an electrode-based device system (e.g., 200 or 300) thatincludes the first electrode. In some example embodiments, a firstnon-tissue based electrically conductive surface may form anelectrically conductive surface of a structure (e.g., 308), thestructure having the first electrode located thereon or therein (e.g.,the electrically conductive surface may be a surface of structuralmember 604-1 b on which another electrode 615-1 b is located, bothstructural members 604-1 a and 604-1 b forming part (e.g., respectiveelongate members 304) of a selectively configurable structure such asstructure 308, the structure 308 also supporting the first electrode,e.g., 615-1 a).

In various embodiments associated with various ones of FIGS. 6A, 6B, 6Cand 6D, the shunt condition includes a diversion of the portion of theenergy transmittable by the first electrode 615-1 a from traveling along(a) a first electrical path extending from the first electrode 615-1 ato the adjacent tissue 621 a, to (b) a second electrical path extendingfrom the first electrode 615-1 a away from the adjacent tissue 621 a,the second electrical path extending through an element that includesthe first non-tissue based electrically conductive surface 630-1.

One or more of electrodes 615-1 a, 615-1 b and structural members 604-1a, 604-1 b may take different forms, shapes or sizes in otherembodiments. It is noted that tissue of a tissue wall against which thefirst electrode is positioned may be sufficiently compliant to allow arespective portion of a shunting element to be depressed into the tissueduring the shunting. For example, in embodiments associated with FIG.6C, (a) respective portion of electrode 615-1 b, (b) a respectiveportion of structural member 604-1 b, or both (a) and (b) may bedepressed into tissue of tissue wall 622 by a different amount thanother elements (e.g., electrode 615-1 a). This may occur, for example,due to positioning or mispositioning of the structure 308 and theparticular contours of the bodily cavity in which it is deployed orexpanded. Various electrodes and structural members depicted in FIG. 6have their dimensions exaggerated for clarity.

It is noted that in some embodiments, the shunt condition includes asmaller portion of the energy transmittable by the first electrode 615-1a being receivable by the adjacent tissue 621 a as compared to anunshunted condition. For example, in various embodiments, an amount ofenergy transmittable by the first electrode 615-1 a and receivable bythe adjacent tissue 621 a will be less in the shunted condition shown inFIG. 6C than in the unshunted condition shown in FIG. 6A. This isschematically represented in FIG. 6C by a relatively fewer number ofelectric field lines 625 a-1 located in the vicinity of adjacent tissue621 a. It is noted that some unshunted conditions may result in asituation where not all of the energy that is transmittable by the firstelectrode is directly deliverable to the adjacent tissue 621 a and thata portion of this transmittable energy may be deliverable or deliveredto another particular entity (e.g. an electrically conductive surfaceprovided by another electrode, structural member, et cetera positionedin the bodily cavity). A magnitude or amount of this portion of thetransmittable energy will typically vary in accordance with the distancebetween the first electrode 615-1 a and the particular entity. However,in various embodiments, a shunt condition may typically result in anincrease in the amount of the transmittable energy that is diverted ascompared to an unshunted condition.

In some example embodiments, the second electrical path also extendsfrom the first electrode 615-1 a to the second electrode 626 a but alonga different path than the first electrical path. An example of this isshown in FIG. 6C in which the second electrical path (represented byelectric field lines 625 b) extends from the first electrode 615-1 a tothe second electrode 626 a via tissue different than adjacent tissue 621a. This situation can occur for various reasons. For example, when thefirst non-tissue based electrically conductive surface 630-1 contactsthe first electrode 615-1 a, the energy transmission surface of thefirst electrode 615-1 a is effectively increased and allows energy to bedelivered to the second electrode 626 a via a different electrical pathor paths. In FIG. 6C, the first non-tissue based electrically conductivesurface 630-1 forms an electrically conductive surface of a structure(e.g., structural member 604-1 b). The first electrode 615-1 a may alsobe located on the structure. In cases where a first non-tissue basedelectrically conductive surface forms a relatively large portion of thestructure (e.g., a back surface 318 b of an elongate member 304 in someembodiments) energy transmission along electrical paths different thanthe first electrical path is likely.

FIG. 6D is a top view like FIG. 6B, but of FIG. 6C, and illustrates theoverlapping of the structural members 604-1 a and 604-1 b over tissuewall 622 a, according to some embodiments. The overlapping edge ofstructural member 604-1 b is illustrated in broken lines, while each ofthe electrodes 615-1 a and 615-1 b also are illustrated in broken lines.In FIG. 6D, the electrode 615-1 a is shunted by the first non-tissuebased electrically conductive surface 630-1. Some of the electric fieldlines 625 a-1 and 625 b are represented by the symbols “●”. The electricfield lines 625 a-1 have a relatively low field density in variousembodiments (as compared to the electric field density shown in FIG.6B). In some cases, low field densities may not be conducive foreffective tissue ablation. Accordingly, the detection of a shuntcondition that may indicate a condition in which these lower electricfield densities may exist is advantageous. In various embodiments, theelectric field lines 625 b have a relatively high field density inregions of contact between the first electrode 615-1 a and the firstnon-tissue based electrically conductive surface 630-1. The electricfield lines 625 b illustrated away from the overlap region betweenstructural members 604-1 a and 604-1 b in FIG. 6D illustrate theelectric field lines that enter the tissue wall 622 a on the right handside of FIG. 6C.

Shunted conditions may also be encountered in other energy transmissionconfigurations. For example, FIGS. 6E and 6F respectively show unshuntedand shunted conditions associated with a first electrode 615-2 a locatedon a structural member 604-2 a (e.g., an elongate member 304). FIG. 6Eschematically depicts first electrode 615-2 a positioned adjacent tissue621 b of a tissue wall 622 b that defines at least part of a bodilycavity 624 b. In this embodiment, energy is transmittable from the firstelectrode 615-2 a to a second electrode 615-2 b along a first electricalpath (schematically depicted at least in part by electric field lines625 c) extending from the first electrode 615-2 a to the secondelectrode 615-2 b. In various embodiments, the second electrode 615-2 bis another electrode positioned within the bodily cavity 624-b. Invarious embodiments, the second electrode 615-2 b is located on astructural member 604-2 b (e.g., an elongate member 304). In variousembodiments, structural members 604-2 a and 604-2 b may form part of aselectively configurable structure such as structure 308. The firstelectrical path may be associated with bipolar ablation in variousexample embodiments associated with FIGS. 6E and 6F. Although anindifferent electrode is not shown in FIGS. 6E and 6F for clarity, it isunderstood that it may be included especially in blendedmonopolar-bipolar applications. It is understood that in variousembodiments, current may flow back and forth between electrodes 615-2 aand 615-2 b in a reciprocating or alternating manner.

FIG. 6F, as compared to FIG. 6E, shows a shunt condition (i.e., alsoreferred to as a shunted condition) associated with various exampleembodiments where a portion of energy transmittable by the firstelectrode 615-2 a is diverted from the first electrical path (e.g., FIG.6E) to a second electrical path schematically depicted at least in partby electric field lines 625 d different than the first electrical path.In some of these example embodiments, the shunt condition is configuredto occur at least due to contact between the first electrode 615-2 a anda first non-tissue based electrically conductive surface 630-2 locatedin the bodily cavity 624 b. In some of these example embodiments, theshunt condition includes a diversion of a portion of the energytransmittable by the first electrode 615-2 a to the first non-tissuebased electrically conductive surface 630-2. As discussed above, anon-tissue based electrically conductive surface, including the firstnon-tissue based electrically conductive surface 630-2, can form part ofany number of different devices. In some embodiments, such as thoseaccording to FIG. 6F, the first non-tissue based electrically conductivesurface 630-2 is provided by a structural member 604-2 c on which athird electrode 615-2 c is located. One or more of electrodes 615-2 a,615-2 b, 615-2 c and structural members 604-2 a, 604-2 b, 604-2 c maytake different forms, shapes or sizes in other embodiments. In variousembodiments associated with FIGS. 6E and 6F, the shunt conditionincludes a diversion of a portion of the energy transmittable by thefirst electrode 615-2 a from traveling along (a) a first electrical pathextending from the first electrode 615-2 a to the adjacent tissue 621 b,to (b) a second electrical path extending from the first electrode 615-2a away from the adjacent tissue 621 b, the second electrical pathextending through an element that includes the first non-tissue basedelectrically conductive surface 630-2. In various embodiments associatedwith FIGS. 6E and 6F, the second electrical path (e.g., represented byelectric field lines 625 d) extends to the second electrode 615-2 b. Invarious embodiments associated with FIGS. 6E and 6F, the secondelectrical path (e.g., represented by electric field lines 625 d)extends to the second electrode 615-2 b via tissue different thanadjacent tissue 621-b. For example, when the first non-tissue basedelectrically conductive surface 630-2 forms a relatively large portionof the structure (e.g., a back surface 318 b of an elongate member 304in some embodiments) energy transmission to the second electrode 615-2 balong electrical paths different than the first electrical path canoccur.

As illustrated in FIG. 6F and discussed above with respect to FIG. 6C,reference 625 a-1, the shunting need not divert all energy transmittableby the first electrode 615-2 a. This circumstance is illustrated byfield lines 625 c-1 which follow the same or approximately the sameportion of the first electrical path illustrated in FIG. 6E.

In some example embodiments, the shunt condition includes at least aportion of the first electrode being overlapped by a physical portion ofan electrode-based device system that includes the first electrode 615-2a. For example, as shown in FIG. 6F, a shunt condition may be associatedwith at least a portion of the first electrode 615-2 a (i.e., located onstructural member 604-2 a) being overlapped by a portion of structuralmember 604-2 c (i.e., as viewed from tissue wall 622 b towards firstelectrode 615-2 a). In some embodiments, the structure on which thefirst electrode 615-2 a is located includes one or more elongate memberswith at least some of a plurality of electrodes that include the firstelectrode 615-2 a being located on each of the one or more elongatemembers. In some embodiments, the shunt condition includes at least aportion of the first electrode 615-2 a being overlapped by an elongatemember of the one or more elongate members when the structure isdeployed in the bodily cavity. It is noted that, in some embodiments,contact may or may not be present between the overlapped portion of thefirst electrode 615-2 a and the overlapping member to cause a shuntcondition.

In this regard, it is noted that a shunt condition detected inaccordance with various embodiments need not necessarily involve contactbetween the first electrode (e.g., electrodes 315-1 a, 615-1 a, 615-2 aor another electrode 415) and some other non-tissue based electricallyconductive surface (e.g., first non-tissue based electrically conductivesurface 630-1 or 630-2). In some embodiments, a shunt condition mayoccur that is associated with a diversion of energy transmittable by thefirst electrode due to the first electrode's proximity, but not contact,to some other non-tissue based electrically conductive surface.

According to some embodiments, a shunt may be an alternate current pathas compared to an original current path that allows current to passthrough a new or different point that was not passed through by currentin the original current path. In some embodiments involving varioustissue ablation applications where lesions are formed in tissue (e.g.,tissue forming a tissue surface), a circuit is formed from an energysource device system (e.g., energy source device system 340 (e.g.,typically in the form of a radio-frequency (RF) generator device systemin some embodiments)) to an electrode (e.g., an electrode 315, 415) ofan electrode based-device system (e.g., electrode-based device system200 or 300), through the tissue of the body, back through anotherelectrode (e.g. an indifferent electrode such as indifferent electrode326 or some other electrode (e.g., some other electrode 315, 415)) ofthe electrode-based device system, and finally back to the energy sourcedevice system. In cardiac ablation procedures, the lesions can provideelectrophysiological blocks configured to block electrophysiologicalactivity in cardiac tissue. In this regard, a lesion typically is formedin close proximity to the electrode where the electrical current densitythrough the tissue is sufficiently high to ablate the tissue. At somedistance from the electrode, the current flows through a large volume oftissue, which causes the electrical current density to be low andtypically results in an insignificant amount of heating. If a firstnon-tissue based electrically conductive surface (e.g., first non-tissuebased electrically conductive surface 630-1 or 630-2) is positionedsufficiently close to the electrode, then the non-tissue basedelectrically conductive surface will provide a low impedance path alongwhich current can flow. The low impedance path will introduce a shuntpath which will divert some of the current to the first non-tissue basedelectrically conductive surface. The diverted current will typicallyalter the distribution of the current density in the tissue.

In the case where the first non-tissue based electrically conductivesurface is in contact with the electrode, the first non-tissue basedelectrically conductive surface typically will form a shunt divertingmost of the current away from tissue proximate the electrode (e.g.,adjacent tissue 621 a or 621 b). The electrical current may be divertedto the tissue surrounding the non-tissue based electrically conductivesurface (e.g., as described above in this disclosure). The effect may besuch that the energy source device system (e.g., an RF generator devicesystem) may see a noticeably lower impedance than when the shuntcondition did not exist. The diverted current will result in an overalllower current density in the tissue adjacent the electrode (e.g.,adjacent tissue which will cause less heating and may typically not forma suitable lesion).

In the case where the first non-tissue based electrically conductivesurface is in sufficiently close proximity to the electrode, but is notcontacting the electrode, the first non-tissue based electricallyconductive surface can provide a lower impedance path which will tend todivert some portion of the electrical current to the first non-tissuebased electrically conductive surface. The volume of any tissue which isin proximity to both the electrode and the non-tissue based electricallyconductive surface may likely see a higher electric current density dueto a portion of the electrical current being diverted from the electrodeto the first non-tissue based electrically conductive surface. In caseswhere the tissue proximate to both the electrode and the firstnon-tissue based electrically conductive surface is blood tissue, thehigher electrical current density could result in excessive heating inthe blood tissue which may lead to undesired thermal coagulum formation.Close proximity between the first non-tissue based electricallyconductive surface and the electrode may have an effect in which theenergy source device system (e.g., an RF generator device system) maylikely see a lower impedance than when the shunt condition does notexist.

FIGS. 6G and 6H respectively represent unshunted and shunted conditionsassociated with a first electrode 615-3 a. FIG. 6G schematically showsfirst electrode 615-3 a positioned adjacent tissue 621 c of a tissuewall 622 c that defines a bodily cavity 624 c. In this example, energyis transmittable from the first electrode 615-3 a to a second electrode626 b (e.g., an indifferent electrode in various embodiments) along afirst electrical path (schematically depicted at least in part byelectric field lines 625 e) extending from the first electrode 615-3 ato the second electrode 626 b. The first electrical path may beassociated with monopolar ablation in various example embodiments. FIG.6H shows a shunt condition (also referred to as a shunted condition)associated with various example embodiments in which a diversion of aportion of energy transmittable by the first electrode 615-3 a from thefirst electrical path (e.g., FIG. 6G) to a second electrical path(schematically depicted at least in part by electric field lines 625 f)different than the first electrical path occurs. In some of theseembodiments, some of the energy continues to be transmittable from thefirst electrode 615-3 a along the first electrical path (i.e.,represented by electric field lines 625 e-1) in the shunted condition.In some of these example embodiments, the shunt condition is configuredto occur at least due to sufficient proximity (e.g., as described abovein this disclosure) between the first electrode 615-3 a and a firstnon-tissue based electrically conductive surface 630-3 located in thebodily cavity 624 c. In some of these example embodiments, the shuntcondition includes a diversion of a portion of the energy transmittableby the first electrode 615-3 a to the first non-tissue basedelectrically conductive surface 630-3. The first non-tissue basedelectrically conductive surface 630-3 can form part of any number ofdifferent devices as described above in this disclosure, and, in thisregard, may, e.g., be a surface of structural member 604-3 b, secondelectrode 615-3 b, or both structural member 604-3 b and secondelectrode 615-3 b. In various embodiments, the first non-tissue basedelectrically conductive surface 630-3 is provided by a structural member604-3 b on which a second electrode 615-3 b is located. Energy in turnflows via an electrical path (i.e., represented by field lines 625 g)from structural member 604-3 b to second electrode 626 b. In embodimentswhere bodily cavity 624 c is an intra-cardiac cavity, blood tissue inregion 627 may be subjected to formation of thermal coagulum due to thehigher energy current density associated with the shunted conditionshown in FIG. 6H. In various embodiments associated with FIG. 6H, theshunt condition includes a diversion of the portion of the energytransmittable by the first electrode 615-3 a from traveling along (a) afirst electrical path extending from the first electrode 615-3 a to theadjacent tissue 621 c, to (b) a second electrical path extending fromthe first electrode 615-3 a away from the adjacent tissue 621 c, thesecond electrical path extending through an element that includes thefirst non-tissue based electrically conductive surface 630-3. In variousembodiments associated with FIG. 6H, the second electrical path (e.g.,represented by electric field lines 625 f and 625 g) extends to secondelectrode 626 b. In various embodiments associated with FIG. 6H, thesecond electrical path (e.g., represented by electric field lines 625 fand 625 g) extends to second electrode 626 b via tissue different thanadjacent tissue 621 c. For example, when the first non-tissue basedelectrically conductive surface 630-3 forms a relatively large portionof the structure (e.g., a back surface 318 b of an elongate member 304in some embodiments) energy transmission to the second electrode 626 balong electrical paths different than the first electrical path andinvolving passage through different tissue can occur.

FIG. 6I illustrates a top view like FIG. 6B and FIG. 6D, but of FIG. 6H,and illustrates the electrodes 615-3 a and 615-3 b as broken lines.Structural member 604-3 a is illustrated over tissue wall 622 c, and thefirst electrode 615-3 a is shunted by structural member 604-3 b due tosufficient proximity of the structural member 604-3 b with the electrode615-3 a, as discussed above with respect to FIG. 6G. Some of theelectric field lines 625 e-1 and field lines 625 g are represented bythe symbols “●”. In various embodiments, the electric field lines 625 femerging from first electrode 615-3 a have a relatively higher electricfield density than the electric field lines 625 e-1 emerging from firstelectrode 615-3 a. The higher electric field density may lead to thermalcoagulation of blood in some cases. One or more of electrodes 615-3 a,615-3 b and structural members 604-3 a, 604-3 b may take differentforms, shapes or sizes in other embodiments. Similar results can occurin bipolar applications. Distances between first electrode 615-3 a andfirst non-tissue based electrically conductive surface 630-3 have beenexaggerated for clarity.

In view of the above discussion pertaining to FIGS. 6G, 6H, and 6I, FIG.5F illustrates an exploded view of block 506 of FIG. 5 according to,among other embodiments, some embodiments pertaining to detection of acondition in which an electrode is too close to (or even improperlycontacts in some embodiments) a non-tissue based electrically conductivesurface. In this regard, block 506 may include a block 506F whoseassociated instructions are configured to cause a detection of aparticular condition based on an analysis of the information acquiredaccording to the acquisition instructions associated with block 504, theparticular condition indicating that a distance between a firstnon-tissue based electrically conductive surface positioned in a bodilycavity (e.g., first non-tissue based electrically conductive surface630-1, 630-2 or 630-3) and a first electrode positioned in the bodilycavity (e.g., first electrode 615-1 a, 615-2 a, or 615-3 a) has beendetected to be less than a target distance between the first non-tissuebased electrically conductive surface and the first electrode. Invarious embodiments, the first electrode is located on a structure(e.g., structure 308) that is positioned in the bodily cavity (e.g.,left atrium 204) in a deployed configuration (e.g., a deployedconfiguration such as shown in FIGS. 3B, 3C and 3D). In variousembodiments, energy sufficient for tissue ablation is transmittable bythe first electrode, at least some of the energy transmittable toadjacent tissue of a tissue wall of the bodily cavity. In variousembodiments, the energy transmittable by the first electrode issufficient for tissue ablation. Again, the first non-tissue basedelectrically conductive surface can form part of any number of differentdevices as described above in this disclosure. In various embodiments,the target distance between the first non-tissue based electricallyconductive surface and the first electrode may be associated with aconfiguration in which the structure on which the first electrode islocated is in a deployed configuration.

In some embodiments, the target distance may be predetermined based onprevious testing to identify the minimum distance between the firstelectrode (e.g., 615-3 a in FIG. 6H) and the first non-tissue basedelectrically conductive surface (e.g., 630-3 in FIG. 6H) that allows forproper energy transmission by the first electrode, e.g., to allow forproper ablation or other functioning. In some embodiments, the targetdistance is a distance between the first electrode and the firstnon-tissue based electrically conductive surface required to reduceoccurrences of a shunt condition, the shunt condition associated with aportion of the energy transmittable by the first electrode beingimproperly diverted to the first non-tissue based electricallyconductive surface. In some embodiments, the target distance isdetermined to be sufficient to limit at least some of the energy that istransmittable from the first electrode to blood to have a magnitudeinsufficient for thermal coagulation of the blood. For example, as shownin FIG. 6G, the first electrode 615-3 a is sufficiently spaced from arespective one of the first non-tissue based electrically conductivesurface 630-3 by a target distance 629 that is sufficient to avoid theshunt condition shown in corresponding FIGS. 6H and 6I. It is noted insome embodiments, that when a shunted condition is not present, adistance between the first electrode and the first non-tissue basedelectrically conductive surface may be greater than an associated targetdistance when a structure on which the first electrode in located is ina deployed configuration. In these embodiments, the target distance maybe interpreted as a minimum desirable distance between the firstelectrode and the first non-tissue based electrically conductive surfacewhen the structure is in the deployed configuration. In variousembodiments, different target distances may be associated with differentfirst electrodes, different first non-tissue based electricallyconductive surfaces or combinations thereof.

Various methods may be employed to detect, determine or characterize adistance between the first electrode and the first non-tissue basedelectrically conductive surface, including various imaging methods. Insome embodiments, electrical impedance based detection/determinationmethods are employed to detect a distance between the first electrodeand the first non-tissue based electrically conductive surface.

FIG. 7 is a schematic block diagram of an electric circuit 700 that isconfigured to determine electrical impedance (e.g., RF impedance)between various objects according to various embodiments. Such a circuit700 may be incorporated into the medical device system of FIG. 1, 3A, or3B, or more particularly, into an electrode-based device system (e.g.,200 or 300), and may provide information according to block 502A or502B.

In various embodiments, electric circuit 700 includes a radio-frequency(RF) driver 702 and respective RF driver voltage and RF driver currentsensing circuits 704 and 706. In FIG. 7, voltage can be sensed using anamplifier 710 and analog to digital converter (ADC) 712. Current can besensed using a current sense transformer 714 with a sense resistor 716(e.g., a 1:100 current sense transformer with a sense resistor). Thevoltage across the sense resistor 716 is amplified via amplifier 718 andsampled using an ADC 720. The signals can be sampled using sequentialsampling to reconstruct the RF waveform. The RF current and voltagewaveforms can then be demodulated into the in-phase and quadrature-phasecomponents. From these components, the complex impedance of the load canbe calculated. In some embodiments, sampled waveforms are used tocalculate the power delivered to the load.

In various embodiments, electrical impedance (e.g., RF impedance) isdetermined between (a) either a first electrode 715-1 (e.g., a firstelectrode 315, 415, 615-1 a, 615-2 a, or 615-3 a) or a first non-tissuebased electrically conductive surface 730, and (b) a second non-tissuebased electrically conductive surface 740. In some embodiments, thefirst non-tissue based electrically conductive surface 730 is a surfaceof a second electrode (other than the first electrode 715-1), and thissecond electrode may be located on the same structure (e.g., 308) onwhich the first electrode 715-1 is located. In some embodiments, thesecond non-tissue based electrically conductive surface 740 is a surfaceof a third electrode (other than the first electrode 715-1 and thesecond electrode), and this third electrode may be located on astructure that may also support the first electrode 715-1, the secondelectrode, or both the first electrode 715-1 and the second electrode.In some embodiments, the second non-tissue based electrically conductivesurface 740 is configured to be positioned outside of a bodily cavity inwhich the first electrode 715-1 is positioned. In some embodiments, thesecond non-tissue based electrically conductive surface 740 isconfigured to be positioned inside a bodily cavity in which the firstelectrode 715-1 is positioned. In some embodiments, the secondnon-tissue based electrically conductive surface 740 is a surface of anindifferent electrode (e.g., indifferent electrode 326, 626 a or 626 b).In some embodiments in which electrical impedance (e.g., RF impedance)is determined between the first electrode 715-1 and the secondnon-tissue based electrically conductive surface 740, the secondnon-tissue based electrically conductive surface 740 forms part of or isa surface of a second electrode (other than the first electrode 715-1)positionable in the bodily cavity. In some embodiments, this secondelectrode is located on the same structure (e.g., 308) on which thefirst electrode 715-1 is located. In some example embodiments, thesecond non-tissue based electrically conductive surface 740 is part of anon-electrode portion of an electrode-based device system (e.g., 200 or300), the electrode-based device system including the first electrode715-1. For example, the second non-tissue based electrically conductivesurface 740 may be a non-electrode portion of a structure (the firstelectrode 715-1 also being located on the structure), the non-electrodeportion appropriately communicatively connected to the circuit 700 forthe impedance determination.

In various embodiments, electrical impedance (e.g., RF impedance) isdetected to assess whether the first electrode 715-1 is in contact withnon-fluidic tissue (e.g., cardiac tissue) forming a surface of a bodilycavity in which the first electrode 715-1 is located or whether thefirst electrode 715-1 is in contact with fluidic tissue (e.g., blood) inthe bodily cavity. For example, fluidic tissue such as blood typicallyhas higher conductivity than non-fluidic tissue such as cardiac tissue.Accordingly, when the first electrode 715-1 is in contact with blood,the electrical impedance will be lower than when the first electrode715-1 is in contact with the cardiac tissue (i.e., tissue forming partof a cardiac tissue wall). Partial contact with blood and cardiac tissuemay lead to intermediate impedance readings. In addition, as noted abovein this disclosure, the proximity of a first non-tissue basedelectrically conductive surface to a first electrode can affect a flowof electrical current and impedance readings between the first electrodeand a second non-tissue based electrically conductive surface such as anindifferent electrode or a second electrode located on a structure onwhich the first electrode is located.

FIG. 5G includes an exploded view of blocks 504 and 506 as employed invarious embodiments. In this regard, block 506 may include a block 506Gwhose associated instructions are configured to cause a detection of aparticular condition based on an analysis of the information acquiredaccording to the acquisition instructions associated with block 504, theparticular condition being a proximity condition indicating proximitybetween a first non-tissue based electrically conductive surface (e.g.,first non-tissue based electrically conductive surface 730) positionedin a bodily cavity and the first electrode (e.g., first electrode 715-1)also positioned in the bodily cavity. The proximity, as with any otherdiscussion of proximity with respect to the detection of at least theproximity condition of block 506G, in some embodiments, may also bereferred to as an improper proximity. In some embodiments, the proximitymay include contact. In some embodiments, the proximity conditionindicates a proximity between a first non-tissue based electricallyconductive surface (e.g., first non-tissue based electrically conductivesurface 730) positioned in a bodily cavity and the first electrode(e.g., first electrode 715-1) also positioned in the bodily cavity whenthe first non-tissue based electrically conductive surface, the firstelectrode, or each of the first non-tissue based electrically conductivesurface and the first electrode contacts a surface of a tissue wall ofthe bodily cavity. In some embodiments, the first electrode may belocated on a structure (e.g., structure 308) which is in a deployedconfiguration. In various embodiments, a particular electrical impedancebetween the first electrode (e.g., 715-1) and a second non-tissue basedelectrically conductive surface (e.g., 740) or changes or variances inthe electrical impedance between the first electrode (e.g., 715-1) andthe second non-tissue based electrically conductive surface (e.g., 740),may be used, at least in part, to detect or characterize proximitybetween the first electrode (e.g., 715-1) and the first non-tissue basedelectrically conductive surface (e.g., 730). It is noted that in someembodiments, a particular electrical impedance between the firstnon-tissue based electrically conductive surface (e.g., 730) and thesecond non-tissue based electrically conductive surface (e.g., 740), orchanges or variances in the electrical impedance between the firstnon-tissue based electrically conductive surface (e.g., 730) and thesecond non-tissue based electrically conductive surface (e.g., 740), maybe used, at least in part, to detect or characterize proximity betweenthe first electrode (e.g., 715-1) and the first non-tissue basedelectrically conductive surface (e.g., 730).

For example, in FIG. 5G, block 504 may include a block 504G-1 whoseassociated instructions include acquisition instructions configured toacquire first information or a derivative of the first informationstored in the memory device system according to the storage instructionsassociated with block 503. In some of these embodiments, the firstinformation or the derivative thereof is indicative of an electricalimpedance between (a) either the first electrode (e.g., 715-1) or thefirst non-tissue based electrically conductive surface (e.g., 730) and(b) a second non-tissue based electrically conductive surface (e.g.,740), the second non-tissue based electrically conductive surface beingother than the first non-tissue based electrically conductive surface,and the second non-tissue based electrically conductive surface notforming part of the first electrode. For example, electrical impedancemay be detected between the first non-tissue based electricallyconductive surface 730 and the second non-tissue based electricallyconductive surface 740 by communicatively connecting (via electricalpath 722 (shown in broken lines)) the first non-tissue basedelectrically conductive surface 730 to transformer 708 instead ofcommunicatively connecting first electrode 715-1 to transformer 708.

In some embodiments, the first information or the derivative thereof isindicative of an electrical impedance between the first electrode (e.g.,first electrode 715-1 or 615-3 a) and a second non-tissue basedelectrically conductive surface (e.g., 740 or a surface of indifferentelectrode 626 b) that is different or other than a first non-tissuebased electrically conductive surface (e.g., provided by structuralmember 604-3 b). If the electrical impedance is lower than a targetelectrical impedance between the first electrode and the secondnon-tissue based electrically conductive surface, the instructionsassociated with block 506G may be configured to detect a proximitycondition in which the first electrode and the first non-tissue basedelectrically conductive surface are insufficiently spaced or improperlyin contact with respect to one another, (e.g., the positioning betweenthe first electrode and the first non-tissue based electricallyconductive surface may be a cause of the unexpectedly low impedance). Itshould be noted that the instructions associated with block 506F in FIG.5F may also use such first information, when it indicates an electricalimpedance lower than the target electrical impedance, to detect acondition in which the first electrode and the first non-tissue basedelectrically conductive surface are within a target distance of eachother.

FIG. 9 includes graphs 902, 904, each representing electrical impedancebetween a first electrode and a second non-tissue based electricallyconductive surface. The electrical impedance in each graph varies as afunction of a distance or spacing between the first electrode and afirst non-tissue based electrically conductive surface that is differentthan the second non-tissue based electrically conductive surface. Eachgraph was generated using data generated by Multiphysics® 4.1, Version4.1.0.88 software provided by Comsol Inc. The modeled first electrodewas representative of an essentially planar electrode structure (e.g.,electrode 315, 415). The modelled first non-tissue based electricallyconductive surface was representative of a structural member similar toelongate member 304, the structural member including an electricallyconductive bottom layer and an electrically insulative top layer. Themodelled second non-tissue based electrically conductive surface wasrepresentative of an electrically conductive surface positionedapproximate 100 mm from the first non-tissue based electricallyconductive surface. Modelled non-fluidic tissue was representative ofmyocardial tissue (i.e., a conductivity of 0.5 S/m was employed).Modeled fluidic tissue was representative of blood (i.e., a conductivityof 0.75 S/m was employed).

Graph 902 is representative of a case in which the entirety of theelectrically conductive surface portion (e.g., an energy transmissionsurface 319) of the first electrode is in contact with non-fluidictissue (e.g., modeled as cardiac tissue forming a tissue wall) and graph904 is representative of a case in which the entirety of theelectrically conductive surface portion of the first electrode is incontact with fluidic tissue (e.g., modeled as blood). It is appreciatedthat various other graphs representative of partial contact between theelectrically conductive surface portion of the first electrode and thenon-fluidic tissue (or between the electrically conductive surfaceportion of the first electrode and the fluidic tissue) may be providedbetween graphs 902 and 904. The electrical impedances associated withgraph 902 (i.e., complete contact with cardiac tissue) are greater thanthe electrical impedances associated with graph 904 (i.e., completecontact with blood) for a given distance or spacing between the firstelectrode and the first non-tissue based electrically conductivesurface. The electrical impedances associated with each of the graphs902 and 904 fall as the spacing between the first electrode and thefirst non-tissue based electrically conductive surface becomes smaller.In the case of graph 902, relatively smaller distances or spacingsbetween the first electrode and the first non-tissue based electricallyconductive surface may be associated with electrical impedances havingvalues low enough to lead to a shunt condition as described above inthis disclosure. Line 906 represents a target electrical impedance thatmay be used according to some embodiments (e.g., a target impedance maybe set 10% below a maximum electrical impedance indicated on graph 902).In FIG. 9, the target electrical impedance is set to 160 ohms. In someembodiments, the target electrical impedance is related to the targetdistance associated with block 506F of FIG. 5F.

Electrical impedance values below that target impedance value indicatedby line 906 may be employed in various embodiments to determine variousconditions such as a shunt condition, a condition indicating a distanceor spacing between the first electrode and the first non-tissue basedelectrically conductive surface or various other conditions (e.g., asdescribed above in this disclosure), especially when complete contactbetween an electrically conductive surface portion of the firstelectrode and the non-fluidic tissue is known to exist. In someembodiments however, a particular contact condition between theelectrically conductive surface portion of the first electrode and thenon-fluidic tissue may not be known. In FIG. 9, graph 908 isrepresentative of a case in which some, but not all, of the electricallyconductive surface portion of the first electrode is in contact with thenon-fluidic tissue. Graph 908 was not modeled using the softwareprovided by Comsol Inc., but rather was added for the convenience ofdiscussion. If an electrical impedance value of 150 ohms was determinedto exist between the first electrode and the second non-tissue basedelectrically conductive surface, various conclusions may be arrived at.For example, a determined impedance value of 150 ohms would be less thanthe target electrical impedance value (e.g., 160 ohms) indicating that ashunt condition likely exists. Alternatively, a determined impedancevalue of 150 ohms may also indicate a condition in which some, but notall, of the electrically conductive surface portion of the firstelectrode is in contact with the non-fluidic tissue. In either case,when the first electrode is operable for transmitting tissue ablationenergy, undesired thermal coagulation of blood may result. If anelectrical impedance value of 135 ohms was determined to exist betweenthe first electrode and the second non-tissue based electricallyconductive surface, various conclusions may be arrived at. For example,a determined impedance value of 135 ohms would be less than the targetelectrical impedance value (e.g., 160 ohms) indicating that a shuntcondition likely exists. Alternatively, a determined impedance value of135 ohms may also indicate a condition in which some amount (evenpossibly all) of the electrically conductive surface portion of thefirst electrode is in contact with the fluidic tissue (e.g., blood). Theformation of thermal coagulum may result in either case if the firstelectrode transmits tissue ablation energy.

Referring back to FIG. 5G, block 504 may include a block 504G-2 that maybe employed in some embodiments. The instructions associated with block504G-2 include acquisition instructions configured to acquire secondinformation or a derivative thereof stored in the memory device systemaccording to the storage instructions associated with block 503. In someembodiments, the second information is indicative of a proximity betweenthe first electrode and non-fluidic tissue (e.g., tissue making up atissue wall of the bodily cavity). In some of these embodiments, thesecond information is indicative of an amount of contact between thefirst electrode and the non-fluidic tissue. As previously indicated,varying amounts of an electrically conductive surface portion of thefirst electrode may be available for contact or may actually makecontact with a non-fluidic tissue surface in various embodiments. Inthis regard, the second information may indicate the amount of contactthat exists between the first electrode and the non-fluidic tissue. Insome embodiments, the detection instructions associated with block 506Gare configured to cause a data processing device system (e.g., 110) todetect the proximity condition (between the first electrode and thefirst non-tissue-based electrically conductive surface) based at leaston the first information acquired in block 504G-1 as discussed above. Insome embodiments, the detection instructions of block 506G areconfigured to cause a data processing device system (e.g., 110) todetect the proximity condition based at least on a combination of thefirst information acquired in accordance with block 504G-1 and thesecond information acquired in accordance with block 504G-2. In thisregard, a deviation from an expected amount ofnon-fluidic-tissue-contact that an electrode experiences may indicatethat something is obstructing the surface of the electrode, such asshown in FIG. 3E. However, since unexpected partial or no contact withnon-fluidic tissue can be caused by other reasons, besides obstructionby another part of an electrode-based device system, it may be helpfulin some embodiments for the second information to include fluid flow(e.g., flow sensing) information, convective heat information, ortemperature information to facilitate a determination of whether, forexample, unexpected partial or no non-fluidic tissue contact is due toobstruction from another part of an electrode-based device system or isdue, e.g., to the electrode being all or partially exposed to a port(instead of fully contacting non-fluidic tissue) that interrupts atissue wall in a bodily cavity. Accordingly, in some embodiments, wherethe proximity condition associated with block 506G is detected based atleast on a combination of the first information and the secondinformation, a data processing device system (e.g., 110) may beconfigured to determine based on an analysis of the first informationand the second information whether such information indicates aproximity between the first electrode and the first non-tissue basedelectrically conductive surface or indicates an amount of contact thatexists between and electrically conductive surface portion of the firstelectrode and a non-fluidic tissue surface (e.g., tissue forming atissue wall) or fluidic tissue (e.g., blood).

In this regard, various methods may be used to detect an amount of anelectrically conductive surface portion of an electrode that contactsnon-fluidic tissue or contacts fluidic tissue. FIG. 8 is a block diagramof an electrical circuit 800 that is configured to detect an amount ofan electrically conductive surface portion of an electrode that contactsnon-fluidic tissue or contacts fluidic tissue, according to someembodiments. Such a circuit 800 may be incorporated into the medicaldevice system of FIG. 1, 3A, or 3B, or more particularly, into anelectrode-based device system (e.g., 200 or 300), and may provideinformation (e.g., at least part of second information referred to inblock 504G-2) according to block 502A or 502B. Electrical circuit 800 isconfigured, according to some embodiments, to determine an electricalresistance of various resistive members 809 employed by varioustransducers (e.g., FIG. 4) 802 a, 802 b, . . . 802 n (collectively 802)which may be positioned in a bodily cavity (e.g., left atrium 204)having one or more ports (e.g., pulmonary vein ostiums (not shown) or amitral valve 226) in fluid communication with the bodily cavity. In someembodiments, a portion (e.g., an electrode surface or a portion thereof)of a first transducer may be positioned in contact with non-fluidictissue (e.g., cardiac tissue) while a portion (e.g., an electrodesurface or a portion thereof) of a second transducer 802 may be incontact with fluidic tissue (e.g., blood). The number of transducers 802employed may vary in different embodiments.

Each resistive member 809 may be formed from copper traces on a flexibleprinted circuit board substrate (e.g., resistive members 409), orresistive elements provided on a structure. Each transducer 802 isdriven by a state machine (not shown) within a controller (e.g.,controller 324), according to some embodiments. In various embodiments,electrical circuit 800 includes a signal source device system 812 and asensing device system 816, each schematically distinguished from oneanother by a broken line in FIG. 8. It is understood that one or both ofsignal source device system 812 and sensing device system 816 may eachinclude different circuitry than those shown in FIG. 8.

In various embodiments, signal source device system 812 provides variousinput signals to at least some of the transducers 802 during atemperature sensing mode. In some embodiments, signal source devicesystem 812 provides various input signals to at least some of thetransducers 802 during a flow sensing mode. In some example embodiments,signal source device system 812 provides various input signals to eachof the transducers 802 during a mapping mode in which informationspecifying a location of various anatomical features within a bodilycavity is provided. For example, information specifying a location ofeach of one or more regions of an interior tissue surface within abodily cavity may be provided along with information specifying alocation of each of at least one of one or more ports on the interiortissue wall with respect to the one or more regions during the mappingmode. In some example embodiments, signal source device system 812provides various input signals to each of the transducers 802 during atissue contact mode in which contact or an amount of contact between aportion (e.g., an electrically conductive surface portion of anelectrode) of each of the various transducers 802 and non-fluidic tissueor a fluidic tissue is made. In some example embodiments, signal sourcedevice system 812 provides various input signals during an ablationmode. In some example embodiments, a state machine (not shown) in thecontroller may be employed to cause various control signals (not shown)to be provided to signal source device system 812 to configureelectrical circuit 800 in at least one of a temperature sensing mode anda flow sensing mode. In some example embodiments, signal source devicesystem 812 includes a radio-frequency generator (not shown) configuredto transfer energy to, or from, the tissue wall. In some exampleembodiments, the radio-frequency generator (not shown) is arranged toprovide a varying electrical current to at least one of the transducers802 to provide energy to tissue from the at least one of the transducers802.

In various embodiments, digital-to-analog converter (DAC) 814 generatesan input signal that is amplified and is driven across the series of theconnected resistive members 809 during a temperature sensing mode.Amplifiers including driver 815 a and driver 815 b are arranged toproduce a balanced output across the series of connected resistivemembers 809. Electrical current driven through resistive members 809 issampled by sensing device system 816. In this example embodiment,electrical current driven through resistive members 809 is sampled ateach of the drivers 815 a, 815 b via respective ones ofanalog-to-digital converters (ADC) 818 a, 818 b. It is noted thatsensing the electrical current at each of the drivers 815 a, 815 b canallow the system to detect possible failures that may result in theelectrical current leaking through another path. Voltage across each ofthe resistive members 809 is also sampled by sensing device system 816via respective ones of analog-to-digital converters (ADC) 819 (threecalled out in FIG. 8). In some embodiments, the current and voltagemeasurements are sampled synchronously with the input signal and thedemodulation of each measurement is computed by the controller.Electrical circuit 800 allows for the electrical resistance of each ofthe resistive members 809 to be precisely determined. The resistance ofan electrically conductive metal (e.g., copper) changes based on thetemperature of the electrically conductive metal. The rate of change isdenominated as a temperature coefficient of resistance (TCR). Theresistance of various ones of the resistive members 809 may be relatedto the temperature of the resistive member 809 by the followingrelationship:R=R ₀*[1+TCR*(T−T ₀)],

where:

R is a resistance of the electrically conductive metal at a temperatureT;

R₀ is a resistance of the electrically conductive metal at a referencetemperature T₀;

TCR is the temperature coefficient of resistance for the referencetemperature (i.e., the TCR for copper is 4270 ppm at T₀=0° C.); and

T is the temperature of the electrically conductive metal.

When signal source device system 812 applies energy to a resistiveelement (e.g., resistive member 809 employed by various transducers 802)positioned within a medium having relatively high flow conditions (forexample, when subjected to blood flow conditions proximate a pulmonaryvein port in the left atrium of a heart or when not shielded from theflow by contact with non-fluidic tissue), the resistive element willheat to a lower temperature and will settle more quickly than if theresistive element were positioned within a medium having relatively lowflow conditions (for example when positioned proximate, or in contactwith a region of a non-fluidic tissue surface within a left atriumpositioned away from the pulmonary vein port). Likewise, when the signalsource ceases to apply energy, the resistive element positioned within amedium having relatively high flow conditions will cool faster and willreturn to ambient temperature faster than if the resistive element wereto be within a medium having relatively lower flow conditions. When thesignal source repetitively applies and ceases to apply energy to theresistive element, the resulting temperature changes of the resistiveelement positioned in a medium having relatively low flow conditionswill appear to have a phase delay compared to the resulting temperaturechanges of the resistive element when positioned in a medium havingrelatively higher flow conditions.

In various embodiments, flow sensing is provided by electrical circuit800 by determining the rate of convective cooling at various ones of theresistive members 809. In some embodiments, when the flow sensing modeis enabled, various ones of the resistive members 809 whose temperatureis determined during the temperature sensing mode can also be employedto deliver energy (i.e., heat) during the flow sensing mode. In variousembodiments, the energy is delivered using the same drivers 815 a, 815 bemployed in the temperature sensing mode. It is understood thatadditional and or alternate drivers may be employed in other exampleembodiments but with additional cost and complexity. When thetemperature sensing mode is not active, the controller system maycontinue to drive an input signal to each of the resistive members 809in various embodiments.

In various embodiments in which the plurality of transducers 802 arearranged within a bodily cavity (e.g., an intra-cardiac cavity such as aleft atrium) having various internal anatomical features, the controllercan provide information specifying a location of at least one of theinternal anatomical features within the bodily cavity based at least inpart on the flow sensing information. As an example, the plurality oftransducers 802 may be arranged within a bodily cavity (e.g., anintra-cardiac cavity such as a left atrium 204) defined at least in partby a tissue wall having an interior tissue surface interrupted by one ormore ports in fluid communication with the bodily cavity (e.g.,pulmonary veins). In such an example, the controller system can provideinformation specifying a location of each of one or more regions of theinterior tissue surface and a location of at least one of the one ormore ports on the interior tissue surface with respect to the one ormore regions based on the flow sensing information. Additionally oralternatively, in some embodiments, contact or an amount of contactbetween a portion of a particular transducer 802 (e.g., an electrodesurface) and non-fluidic tissue or fluidic tissue may be determinedbased at least in part on the flow sensing information.

Although the above disclosure often is described in the context of‘transmittable energy’ to emphasize a typical desire to detectpotentially improper energy delivery conditions before energy isdelivered, it should be noted that the invention is not limited to thiscontext and some embodiments pertain to the detection of the particularconditions (e.g., block 506) during energy delivery. In this regard, insome embodiments, the above-discussed context of ‘transmittable energy’may be replaced with the context of ‘energy that is or is beingtransmitted’ or the like to pertain to detection of conditions duringenergy delivery.

Further, the above disclosure describes various techniques for detectingvarious particular conditions (e.g., block 506), and some of thesetechniques are described within a context of detecting one or moreparticular conditions. However, it should be noted that any of thetechniques for detecting a condition may be used to detect any of theother conditions discussed above. For example, the techniques fordetecting a shunt condition (e.g., FIG. 5D) may be used to detectcontact between a non-tissue based surface and an electricallyconductive surface portion of an electrode (e.g., FIG. 5C), to detect acondition where some, but not all, of an electrically conductive surfaceportion of an electrode is available for contact (e.g., FIG. 5B), todetect a deviation in an expected positioning of at least a portion ofan electrode-based device system (e.g., FIGS. 5A and 5E), to detect acondition indicating a distance between a first non-tissue basedelectrically conductive surface and a first electrode is less than atarget distance (e.g., FIG. 5F), or a combination thereof, becausedetecting a shunt condition involving an electrode of an electrode-baseddevice system can indicate all of such conditions. In this regard, itshould be noted that any of the techniques for detecting a conditionpursuant to FIGS. 5 and 5A-5G may be used to detect any of the otherconditions of FIGS. 5 and 5A-5G.

Further still, it should be noted that an electrode-based device systemneed not take the respective forms shown by electrode-based devicesystem 200 or electrode-based device system 300, and that any form ofelectrode-based device system may be used in which a condition discussedabove may be detected, whether such electrode-based device systemincludes electrodes of the configuration shown in FIG. 4 or otherwise.

While some of the embodiments disclosed above are described withexamples of cardiac ablation, the same or similar embodiments may beused for ablating other bodily organs or any lumen or cavity into whichthe devices of the present invention may be introduced.

Subsets or combinations of various embodiments described above providefurther embodiments.

These and other changes can be made to the invention in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the invention to thespecific embodiments disclosed in the specification and the claims, butshould be construed to include other electrode-based device systemsincluding all medical treatment device systems and all medicaldiagnostic device systems in accordance with the claims. Further, itshould be noted that, although several of the above-discussedembodiments are described within the context of an intra-cardiac medicaldevice system, the invention applies to other medical and non-medicaldevice systems, such as an device system in which detecting one or moreimproper energy transmission configurations is beneficial. Accordingly,the invention is not limited by this disclosure, but instead its scopeis to be determined entirely by the claims.

What is claimed is:
 1. A method executed by a data processing devicesystem according to a program stored by a memory device systemcommunicatively connected to the data processing device system, themethod comprising: receiving first information from an electrode-baseddevice system; storing the first information or a derivative thereof inthe memory device system; acquiring information stored in the memorydevice system, the information including the first information or thederivative thereof; detecting a shunt condition created in an electriccircuit based at least upon an analysis of a result of an interactionbetween (a) one or more electrical signals insufficient for tissueablation provided by at least one electrode of one or more electrodes ofthe electrode-based device system, and (b) a tissue wall that defines atleast part of a bodily cavity, the electric circuit comprising at leasta first electrode of the one or more electrodes of the electrode-baseddevice system, the electrode-based device system comprising a structureand the one or more electrodes located on the structure, the one or moreelectrodes positionable in the bodily cavity, and the shunt conditionassociated with a diversion of a portion, but not all, of energytransmittable by the first electrode of the one or more electrodes awayfrom adjacent tissue of the tissue wall, the adjacent tissue adjacentthe first electrode of the one or more electrodes, and the energytransmittable by the first electrode of the one or more electrodessufficient for tissue ablation; and storing, in the memory devicesystem, detection information indicating the detection of the shuntcondition, wherein the first information or the derivative thereofindicates the result of the interaction between the one or moreelectrical signals and the tissue wall.
 2. The method of claim 1,further comprising restricting the energy transmittable by the firstelectrode of the one or more electrodes in response to the detectedshunt condition.
 3. The method of claim 1, wherein an input-outputdevice system is communicatively connected to the data processing devicesystem, and wherein the input-output device system comprises theelectrode-based device system.
 4. The method of claim 3, furthercomprising causing the first electrode to transmit the energy anddiverting the portion of the energy transmitted by the first electrodeto an electrically conductive portion of the structure that does notform part of any electrode to cause the shunt condition.
 5. The methodof claim 3, further comprising causing the first electrode to transmitthe energy and diverting the portion of the energy transmitted by thefirst electrode to a metallic portion of the structure that does notform part of any electrode to cause the shunt condition.
 6. The methodof claim 3 wherein the structure of the electrode-based device systemcomprises a plurality of elongate members, wherein the one or moreelectrodes comprise a plurality of the electrodes, at least some of theplurality of the electrodes located on each of the plurality of elongatemembers, wherein the first electrode of the one or more electrodes islocated on a first elongate member of the plurality of elongate members,wherein the information acquired according to the acquiring includespositional information indicative of a deviation in an expectedpositioning between the first electrode of the one or more electrodesand at least a second elongate member of the plurality of elongatemembers, and wherein the first elongate member is other than the secondelongate member.
 7. The method of claim 6 wherein the structure isselectively moveable between a delivery configuration in which thestructure is sized for percutaneous delivery to the bodily cavity and adeployed configuration in which the structure is sized too large forpercutaneous delivery to the bodily cavity.
 8. The method of claim 1wherein the shunt condition is associated with a diversion of theportion of energy transmittable by the first electrode of the one ormore electrodes from traveling along (a) a first electrical pathextending from the first electrode of the one or more electrodes to theadjacent tissue of the tissue wall, to (b) a second electrical pathextending from the first electrode of the one or more electrodes awayfrom the adjacent tissue of the tissue wall.
 9. The method of claim 1wherein the shunt condition is associated with a diversion of theportion of energy transmittable by the first electrode of the one ormore electrodes to a second electrode positionable in the bodily cavity.10. The method of claim 1 wherein the one or more electrodes includes asecond electrode, and the shunt condition is associated with a diversionof the portion of energy transmittable by the first electrode of the oneor more electrodes to the second electrode of the one or moreelectrodes.
 11. The method of claim 1 wherein an input-output devicesystem is communicatively connected to the data processing devicesystem, and wherein the method further comprises causing theinput-output device system to present an error notification to a user inresponse to the detection of the shunt condition.
 12. The method ofclaim 1 wherein the shunt condition is configured to occur at least dueto contact between the first electrode of the one or more electrodes anda non-tissue based electrically conductive surface positionable in thebodily cavity.
 13. The method of claim 12 wherein the non-tissue basedelectrically conductive surface does not form part of any electrode. 14.The method of claim 1 wherein the shunt condition is configured to occurat least due to contact between the first electrode of the one or moreelectrodes and a metallic surface positionable in the bodily cavity. 15.The method of claim 1 wherein the shunt condition is configured to occurat least due to contact between the first electrode of the one or moreelectrodes and an electrically conductive portion of the structure thatdoes not form part of any electrode.
 16. The method of claim 1 whereinthe shunt condition is configured to occur at least due to contactbetween the first electrode of the one or more electrodes and a secondelectrode positionable in the bodily cavity.
 17. The method of claim 1wherein the one or more electrodes include a second electrode, andwherein the shunt condition is configured to occur at least due tocontact between the first electrode of the one or more electrodes andthe second electrode of the one or more electrodes.
 18. The method ofclaim 1 wherein the information acquired according to the acquiringincludes impedance information associated with at least the firstelectrode of the one or more electrodes.
 19. The method of claim 1wherein the information acquired according to the acquiring includespositional information indicative of a deviation in an expectedpositioning between the first electrode of the one or more electrodesand a physical portion of the electrode-based device system.
 20. Themethod of claim 1 wherein the information acquired according to theacquiring includes positional information indicative of a deviation inan expected positioning between a portion of the structure and theadjacent tissue of the tissue wall.
 21. The method of claim 1 whereinthe electric circuit comprises a first electrical path extending atleast from the first electrode of the one or more electrodes to a secondelectrode.
 22. The method of claim 21 wherein the first electrical pathextends at least from the first electrode of the one or more electrodesto the second electrode via the adjacent tissue, wherein the shuntcondition is associated with a diversion of the portion of energytransmittable by the first electrode from the first electrical path to asecond electrical path other than the first electrical path, the secondelectrical path extending from the first electrode of the one or moreelectrodes to the second electrode.
 23. The method of claim 22 whereinthe second electrical path extends from the first electrode of the oneor more electrodes to the second electrode via an electricallyconductive portion of the structure not comprising any electrode and viatissue other than the adjacent tissue.
 24. The method of claim 21wherein the second electrode is an indifferent electrode positionedoutside of the bodily cavity.
 25. The method of claim 21 wherein thesecond electrode is configured to be positioned in the bodily cavity.26. The method of claim 21 wherein the one or more electrodes includesthe second electrode.
 27. The method of claim 1 wherein the shuntcondition is associated with a smaller portion of the energytransmittable by the first electrode of the one or more electrodes beingreceivable by the adjacent tissue as compared to an unshunted condition.28. The method of claim 1 wherein the shunt condition is associated withan increase in the diversion of the portion of the energy transmittableby the first electrode of the one or more electrodes.
 29. A medicaldevice system comprising: a data processing device system; a memorydevice system communicatively connected to the data processing devicesystem and storing a program executable by the data processing devicesystem, the program comprising: reception instructions configured tocause reception of first information from an electrode-based devicesystem; first storage instructions configured to cause a storage of thefirst information or a derivative thereof in the memory device system;acquisition instructions configured to cause an acquisition ofinformation stored in the memory device system, the informationincluding the first information or the derivative thereof; detectioninstructions configured to cause a detection of a shunt conditioncreated in an electric circuit based at least upon an analysis of aresult of an interaction between (a) one or more electrical signalsinsufficient for tissue ablation provided by at least one electrode ofone or more electrodes of the electrode-based device system, and (b) atissue wall that defines at least part of a bodily cavity, the electriccircuit comprising at least a first electrode of the one or moreelectrodes of the electrode-based device system, the electrode-baseddevice system comprising a structure and the one or more electrodeslocated on the structure, the one or more electrodes positionable in thebodily cavity, and the shunt condition associated with a diversion of aportion, but not all, of energy transmittable by the first electrode ofthe one or more electrodes away from adjacent tissue of the tissue wall,the adjacent tissue adjacent the first electrode of the one or moreelectrodes, and the energy transmittable by the first electrode of theone or more electrodes sufficient for tissue ablation; and secondstorage instructions configured to cause a storage in the memory devicesystem of detection information indicating the detection of the shuntcondition according to the detection instructions, wherein the firstinformation or the derivative thereof indicates the result of theinteraction between the one or more electrical signals and the tissuewall.
 30. A medical device system comprising: a data processing devicesystem; a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system, wherein the data processing device system isconfigured by the program at least to: receive first information from anelectrode-based device system; store the first information or aderivative thereof in the memory device system; acquire informationstored in the memory device system, the information including the firstinformation or the derivative thereof; detect a shunt condition createdin an electric circuit based at least upon an analysis of a result of aninteraction between (a) one or more electrical signals insufficient fortissue ablation provided by at least one electrode of one or moreelectrodes of the electrode-based device system, and (b) a tissue wallthat defines at least part of a bodily cavity, the electric circuitcomprising at least a first electrode of the one or more electrodes ofthe electrode-based device system, the electrode-based device systemcomprising a structure and the one or more electrodes located on thestructure, the one or more electrodes positionable in the bodily cavity,and the shunt condition associated with a diversion of a portion, butnot all, of energy transmittable by the first electrode of the one ormore electrodes away from adjacent tissue of the tissue wall, theadjacent tissue adjacent the first electrode of the one or moreelectrodes, and the energy transmittable by the first electrode of theone or more electrodes sufficient for tissue ablation; and store, in thememory device system, detection information indicating the detection ofthe shunt condition, wherein the first information or the derivativethereof indicates the result of the interaction between the one or moreelectrical signals and the tissue wall.
 31. A non-transitorycomputer-readable storage medium system comprising one or morenon-transitory computer-readable storage mediums storing a programexecutable by one or more data processing devices of a data processingdevice system, the program comprising: a reception module configured tocause reception of first information from an electrode-based devicesystem; a first storage module configured to cause a storage of thefirst information or a derivative thereof in a memory device system; anacquisition module configured to cause an acquisition of informationstored in a memory device system, the information including the firstinformation or the derivative thereof; a detection module configured tocause a detection of a shunt condition created in an electric circuitbased at least upon an analysis of a result of an interaction between(a) one or more electrical signals insufficient for tissue ablationprovided by at least one electrode of one or more electrodes of theelectrode-based device system, and (b) a tissue wall that defines atleast part of a bodily cavity, the electric circuit comprising at leasta first electrode of the one or more electrodes of the electrode-baseddevice system, the electrode-based device system comprising a structureand the one or more electrodes located on the structure, the one or moreelectrodes positionable in the bodily cavity, and the shunt conditionassociated with a diversion of a portion, but not all, of energytransmittable by the first electrode of the one or more electrodes awayfrom adjacent tissue of the tissue wall, the adjacent tissue adjacentthe first electrode of the one or more electrodes, and the energytransmittable by the first electrode of the one or more electrodessufficient for tissue ablation; and a second storage module configuredto cause a storage in the memory device system of detection informationindicating the detection of the shunt condition according to thedetection module, wherein the first information or the derivativethereof indicates the result of the interaction between the one or moreelectrical signals and the tissue wall.